| [Health Resources and Services Administration, HIV/AIDS Bureau] | [Table of Contents] | [Substance Abuse and Mental Health Administration] |
National Institutes of Allergy and Infectious Diseases (NIAID)
Purpose Of The Database And Study Design: The AACTG, the largest HIV clinical trials organization in the world, plays a major role in setting standards of care for HIV infection and opportunistic diseases related to HIV/AIDS in the US and the developed world. The AACTG has been pivotal in providing the data necessary for the approval of therapeutic agents, as well as the treatment and prevention strategies, for many OIs and malignancies. The AACTG is composed of, and directed by, leading clinical scientists in HIV/AIDS therapeutic research.
Nature Of The Data Collected: Baseline and followup data collected for efficacy evaluations of HIV therapies within large-scale, multi-site clinical trials. Endpoints may include clinical outcomes, CD4 cell counts, or HIV RNA load.
Unit Of Analysis: HIV positive adults
General Attributes: Studies typically include several hundred subjects in each treatment arm.
Major Data Constructs And Key Data Elements: Through innovative hypothesis-based and pathogenesis-oriented studies of the treatment of HIV-1 infection and its sequelae, AACTG research focuses on:
Strengths And Weaknesses Of The Study Design And Database: Not available.
Gaps In The Data Collected And Factors Leading To The Gaps: None identified.
Feasibility Of Linking With Other Databases: Study subject names are strictly confidential and no identifying information is available.
For more information see the AACTG web site at: aactg.s-3.com. The following NIAID AACTG data sets have been submitted to NTIS for public use:
Selected Citations:
Bakshi S. Evaluation of pharmacokinetics, safety, tolerance, and activity of combination zalcitabine and zidovudine (ZDV) in stable, ZDV-treated, pediatric patients with HIV infection. Journal of Infectious Diseases. 175:1039-1050, 1997.
Boucher F. Phase I evaluation of zidovudine administered to infants exposed at birth to the human immunodeficiency virus. Journal of Pediatrics. 122(1): 137-144, 1993.
Brady M. Randomized study of the tolerance and efficacy of high versus low dose zidovudine in HIV positive children with mild to moderate symptoms (ACTG 128). Journal of Infectious Diseases. 173(5): 1097-1106, 1996.
Connor E. Reduction of maternal-infant transmission of human immunodeficiency virus 1 with zidovudine treatment: results of AIDS Clinical Trial Group Protocol 076. NEJM. 331(18): 1173-1180, 1994.
England J. Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV positive children. NEJM. 336(24) 1704-1712, 1997.
Kline M. A randomized comparative trial of stavudine (d4T) versus zidovudine (ZDV, AZT) in children with human immunodeficiency virus infection. Pediatrics. 101(2): 214-220, 1998.
Luzuriaga K. Phamacokinetics, safety, and activity of nevirapine in HIV Type 1 infected children. Journal of Infectious Diseases. 174: 713-721, 1996.
Luzuriaga K. Combination treatment with zidovudine, didanosine, and nevirapine in infants with human immunodeficiency virus Type 1 infection. NEJM. 336(19): 1343-1349, 1997.
McKinney R. Safety and tolerance to intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Journal of Pediatrics. 116(4): 640-647, 1990.
McKiney R. A multicenter trial of oral zidovudine in children with advanced human immunodeficiency virus disease. NEJM. 324(15): 1018-1025, 1991.
O’Sullivan M. The pharmacokinetics and safety of zidovudine in the third trimester of pregnancy for women infected with human immunodeficiency virus and their infants: Phase I Acquired Immunodeficiency Syndrome Clinical Trials Group Study (Protocol 082). American Journal of Obstetrics and Gynecology. 168(5): 1510-1516, 1993.
Shearer W. Transport of recombinant human CD4-immunoglobulin G across the human placenta: pharmakinetics and safety in six mother-infant pairs in AIDS Clinical Trials Group Protocol 146. Clinical and Diagnostic Laboratory. 2(3) 281-285, 1995.
Spector S. A controlled trial of intravenous gamma globulin for prevention of serious bacterial infections in children receiving zidovudine for advanced human immunodeficiency virus infection. NEJM. 331(18): 1181-1187, 1994.
NIAID
Purpose Of The Database And Study Design: The ALIVE cohort is an ongoing prospective study of HIV disease in out-of-treatment drug users residing in Baltimore. The cohort was recruited and screened for HIV infection in 1987 and 1988, 1994, and 1998. The objectives of the study are to: determine the course of HIV infection by characterizing the rate of progression to AIDS, immunosuppression, specific disease outcomes, and HIV-related mortality; identify markers of progression to clinical outcomes and levels of immunosuppression; identify the effect of HIV progression on drug use and sexual behaviors; evaluate the impact of specific gynecological conditions on progression in women; identify survival times from clinical and laboratory endpoints and factors associated with rapid progression and long-term survival; and collaborate using the ALIVE cohort for additional studies.
Nature Of The Data Collected: Longitudinal collection of physical examination, clinical specimens, and interview data
Unit Of Analysis: HIV positive and uninfected adolescent study subjects
Data Collection Methods: Injecting drugs users in Baltimore were recruited to participate in the study through dissemination of information about the study by a variety of community-based organizations. Eligibility for enrollment in the study included being 18 years of age or older, a history of injecting illicit drugs at any time within the previous 11 years, and being free of an AIDS-defining condition at baseline. At the baseline visit, eligible and consenting injecting drug users were enrolled and assigned a unique identifier on data collection instruments. After blood samples were taken, each participant received a face-to-face interview. A standardized baseline interview obtained demographic characteristics, medical history, and history of drug injection and sexual practices. All HIV seropositive subjects and a sample of seronegatives were enrolled in a longitudinal follow-up arm of the study. HIV seronegative study subjects were encouraged to return every six months for screening and an interview. At each six-month follow-up interview, HIV seronegative subjects were interviewed about their injecting drug use behavior and sexual practices during the past six months. HIV positive subjects were interviewed and given physical examinations at six-months intervals.
General Attributes: A total of 2,921 participants have enrolled in the study.
Major Data Constructs And Key Data Elements: Data collected at six-month intervals includes: demographic characteristics, signs and symptoms of HIV-related disease, licit and illicit drug use behaviors, use of HIV-related therapeutics, sexual history and practices, and frequency of condom use. A physical and brief neurological examination is conducted. Pap smears and pelvic examinations are conducted on women and cervical specimens obtained by cervico-vaginal lavage. At each visit, blood is drawn for serologic and immunologic testing.
Strengths And Weaknesses Of The Study Design And Database: The ALIVE cohort represents a long-standing, well-studied group of injecting drug users.
Gaps In The Data Collected And Factors Leading To The Gaps: None identified.
Feasibility Of Linking With Other Databases: Other databases have been linked to the ALIVE database including the HARS and Medicaid eligibility and claims files.
Process To Access The Database And Contact Person:
Selected Citations:
Solomon L, Vlahov D, Astemborski J, Galai N, et al. Factors associated with initiation of zidovudine in a cohort of injection drug users. Journal of Drug Issues. 25(1): 225-233, 1995.
Vlahov D, Munoz A, Solomon L, Astemborski J, et al. Comparison of clinical manifestations of HIV infection between male and female injecting drug users. AIDS. 8(6): 819-923, 1994.
Vlahov D, Astemborski J, Solomon L, Nelson KE. Field effectiveness of needle disinfection among injecting drug users. Journal of AIDS. 7(7): 760-766, 1994.
Astemborski J, Vlahov D, Warren D, Solomon L, et al. The trading of sex for drugs or money and HIV seropositivity among female intravenous drug users. AJPH. 84(3): 382-387, 1994.
Solomon L, Astemborski J, Warren D, Munoz A, et al. Differences in risk factors for human immunodeficiency virus type 1 seroconversion among male and female intravenous drug users. American Journal of Epidemiology. 137(8): 892-898, 1993.
NIAID
Purpose Of The Database And Study Design: CPCRA was established in 1989 to broaden the scope of the HIV research effort of NIAID to include clinical trials conducted in community-based settings. The main goal of the CPCRA is to obtain evidence to properly inform health care providers and people living with HIV about the most appropriate use of available HIV therapies in diverse populations across the spectrum of HIV disease.
The CPCRA is a network of community-based health care providers who have integrated scientific research into primary care. It now includes 15 research units, a statistical center, and an operations center. Research units are based in a variety of primary care settings, including private practices, community clinics, university outpatient departments, and VA hospitals. Located in 14 cities across the US, these 15 units and their patient base represent diverse geographic, racial, and risk groups. The CPCRA offers access to a large number of patients whose demographic characteristics reflect those of the evolving HIV epidemic. The CPCRA has established clinician/patient relationships that enhance patient retention and compliance in clinical studies and allow for long-term follow-up.
The scientific agenda for the CPCRA focuses on answering key clinical management questions that face providers and patients every day. The agenda is constructed around a core of antiretroviral treatment trials. CPCRA trials are designed with nested substudies aimed at understanding the pathogenesis of HIV infection and the public health implications of its treatment. These trials are complemented with substudies and other trials focused on issues of current interest. Antiretroviral and immunomodulatory research focuses on studies designed to determine the durability of virologic suppression of initial drug regimens and evaluate the virologic changes caused by second- and third-line regimens, as well as analyze the clinical consequences of the entire treatment sequence. The CPCRA plans to investigate the clinical outcome of patients with early HIV infection who receive an immunomodulator, as well as investigate various treatment combinations and sequences in this patient population.
The CPCRA studies how the spectrum of complication of HIV disease is changing and whether OI prophylaxis and treatment strategies should be modified. In addition, the CPCRA is interested in nutritional and metabolic disregulation and their effects on the pathogenesis, treatment, and clinical course of HIV disease.
The ODB is a data file of baseline and disease incidence information on 5,104 HIV positive patients enrolled between September 1990 and November 1992. Baseline variables include demographic characteristics, treatments, CD4 count, and HIV risk factors. Follow-up data through July 1, 1994 are included for 44 different incident opportunistic events and death.
Process To Access The Database And Contact Person: For additional information contact: Jonathan Kagan, MD, Therapeutics Research Program, DAIDS, NIAID, (301) 402-0131. Information regarding the CPCRA studies listed below may be obtained from the NTIS.
| Study # | Title | NTIS Reference # |
|---|---|---|
| 001 | A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV positive Individuals with Serologic Evidence. | PB95-503405GEI (diskette and
protocol) PB95-19151 (documentation only) |
| 002 | A Prospective, Randomized Open-Label, Comparative Trial of Dideoxyinosine versus Dideoxycytidine in HIV positive Patients Who Are Intolerant of or Who Failed Zidovudine Therapy. | PB95-503413GEI (diskette and
protocol) PB95-191169 (documentation only) |
| CPCRA Observational Data Base | PB96-500897 | |
| CPCRA Cross-Study Data Base | PB96-500889 |
Selected Citations:
Please refer to the CPCRA webpage for a complete and up-to-date listing of abstracts and publications: http://www.cpcra.org/publications/.
Burns DN, Hillman D, Neaton JD, Sherer R, Mitchell T, Capps L, Vallier WG, Thurnherr MD, Gordin FM. Cigarette smoking, bacterial pneumonia and other clinical outcomes in HIV-1 Infection. JAIDS, 13(4): 374-383, 1996.
Torres RA, Neaton JD, Wentworth D, Barr MR, Abrams D, Sherer R, Ward T, Sampson J. Acyclovir and survival in an observational cohort enrolled by the Community Programs for Clinical Research on AIDS (CPCRA). Clin Infect Dis, 26: 85-90, 1996.
Melnick SL, Sherer R, Louis TA, Hillman D, Rodriguez EM, Lackman, Capps L. Survival and disease progression according to gender of patients with HIV infection. JAMA. 272(24): 1915-1921, 1996.
NIAID
Purpose Of The Database And Study Design: HIVNET was established in 1993 by the Division of AIDS (DAIDS), NIAID to be a multi-center, collaborative research network whose mission is to carry out HIV prevention efficacy trials. Its purpose was to evaluate the safety and effectiveness of promising interventions to prevent the transmission of HIV between sexual and/or needle-sharing partners, as well as from mother to baby during pregnancy and at birth. In most cases, the primary aim of these studies is to measure the effect of prevention interventions on reducing the number of new HIV infections.
The HIVNET has had a broad agenda that includes trials of vaccines, topical microbicides, treatment of sexually transmitted diseases, behavioral interventions, and approaches to prevent mother-to-infant transmission. It focuses primarily on efficacy trials (although it has carried out some Phase I and II studies) in an international multi-center network. Scientific collaborations with scientists in industry and academia, and NIAID staff constitute other key components of the program. The clinical research sites of the HIVNET are located in the US and abroad. Twenty-two research sites are currently located in eleven cities in the US. Eleven international sites are located in Asia, Africa, the Caribbean, and South America.
HIVNET's studies are often carried out in collaboration with other agencies that are involved in prevention research including NIMH, NIDA, the National Institute of Child Health and Human Development (NICHD), the National Institute on Alcohol Abuse and Alcoholism, Fogarty International Center, CDC, Walter Reed Army Institute of Research, the US Agency for International Development, the Population Council, the Contraceptive Research and Development Program, the United Nations AIDS program, and the World Health Organization.
In 1999, a plan for reconfiguration of the NIAID’s clinical prevention research and development program emerged from an eight-month process of evaluation and discussion involving a broad cross-section of the scientific and at-risk communities. The plan preserves important assets of the current program, minimizes disruption of ongoing and planned studies, ensures scientific and managerial continuity, creates greater opportunity for scientific creativity, and allows the possibility for institutions to participate in both areas of clinical research and development. The plan calls for the reconfiguration of HIVNET and the AIDS Vaccine Evaluation Group (AVEG) to create:
An orderly transition process has been undertaken to consolidate scientific responsibility for HIV vaccine research and development in the HVTN. Similarly, other areas of clinical prevention research currently under the purview of HIVNET will be consolidated in the HPTN. The transition will proceed through a two-stage process. The first stage will consist of establishing separate vaccine and prevention leadership core groups. The second stage will be the selection of the clinical sites.
Unit Of Analysis: Individuals at risk for HIV Infection
General Attributes: The Vaccine Preparedness Study (VPS) (HIVNET Protocol D01) was completed in January 1998. VPS had 4,892 participants from three groups at high risk for HIV: injection drug users, men who have anal intercourse (receptive or insertive) with other men, and women at high risk for HIV infection through heterosexual contact. In August 1997, an expansion of the VPS was launched with the recruitment of new groups of injection drug users at HIVNET sites in Philadelphia and New York City. The expansion continued in February 1998 with the start of recruitment of individuals in the three high risk groups at five pre-existing and three new HIVNET sites, in Baltimore, Los Angeles, and the Bronx.
Additional vaccine studies include: Safety Trial of Two HIV Vaccine Strategies in HIV-Negative Volunteers (HIVNET Protocol 014), HIV-Exposed But Uninfected Study (HIVNET Protocol D01.3), and the Infected Participant Cohort (IPC) (HIVNET Protocols D01.1 and 019).
Microbicide studies include: PMPA Gel Vaginal Microbicide Study (HIVNET Protocol 018), Phase 1 Rectal Microbicide Study (HIVNET Protocol 008), and the Vaginal Microbicide Study of Buffergel PRO 2000/5 Gel Study.
Behavioral studies include: HIV Early Detection Study (HEDS) (HIVNET D01.2), a trial of a behavioral intervention for men who have sex with men (HIVNET Protocol 015, "EXPLORE"), and an application of computer technology to assess risk behaviors among participants in the Vaccine Preparedness Study of HIVNET (HIVNET Protocol 005).
Strengths And Weaknesses Of The Study Design And Database: The HIVNET has a track record of carrying out important studies in the relevant areas of science and has made many significant contributions to the field of prevention research. It has had an active agenda and established systems and procedures. There is extensive integration of communities at-risk into the research program. There are well-established central laboratories and working structures for utilizing them and the data that are generated by them. The HIVNET funding structure is designed for the specific purpose of creating a network upon which a vaccine efficacy trial could be placed. It uses sites and "infrastructure" as its fundamental organizing principal, rather than science.
HIVNET has depended on additions to the infrastructure through incremental funding for particular clinical trials. This led to substantial variation in year-to-year funding levels and considerable difficulty in establishing scientific priorities when the funding base has been unpredictable. The "compartmentalization" of vaccine development, where Phase I and Phase II vaccine trials are in AVEG and Phase III in HIVNET, has made it difficult to ensure maximal efficiency and a "seamless" program of vaccine development. This has required coordination across two different organizations with varied scientific focus and priorities, laboratories, and data collection and analysis systems.
Feasibility Of Linking With Other Databases: None
Process To Access The Database And Contact Person: For additional information contact: Lawrence Corey, MD, Fred Hutchinson Cancer Research Center, University of Washington, (206) 667-6702. The HIVNET website is: http://www.hivnet.commed.net/.
NIAID
Purpose Of The Database And Study Design: MACS is a study of HIV infection in homosexual and bisexual men. Selected participants currently being followed include: HIV positive men who were enrolled in the study as seroprevalent cases or who have seroconverted while in the study; HIV-seronegative men at high risk of HIV-infection based on behavioral assessments, and a matched set of seronegative men who are at lower risk of HIV infection. NIAID plans to follow these subjects through at least 2005. MACS data have been used to conduct an array of HIV research including: clinical effects of therapy, trends in survival, and trends in HIV-related clinical events; correlation of host immune responses to the development of HIV disease; use of viral load as a predictor of outcome following seroconversion; use of viral factors including HIV phenotyping to determine disease outcome; trends in health service use; and HIV-related neuropsychological outcomes.
Nature Of The Data Collected: Longitudinal collection of clinical specimens and interview data
Unit Of Analysis: A matched cohort of HIV positive and seronegative men
Data Collection Methods: MACS subjects are followed at the clinical centers at six-month intervals. During their visits, they respond to a detailed health questionnaire, receive a physical examination, and have blood specimens taken. These specimens are processed and stored as frozen serum, plasma, and cells in the NIAID AIDS Specimen Repository. Additional samples of blood and other body fluids and tissues are collected for specific MACS pathogenesis protocols.
General Attributes: Over 5,500 men have participated in the MACS since the initial enrollment in 1984. MACS clinical centers include Baltimore, Pittsburgh, Chicago, and Los Angeles. Over one million specimens are housed in the NIAID AIDS Specimen Repository.
Major Data Constructs And Key Data Elements: Data collected include: immunologic, virologic, and other biologic determinants of disease progression, factors that are associated with HIV-mediated immune system destruction; and factors that might protect individuals from becoming HIV positive. Interview data include detailed questions regarding: sexual practices, HIV-related symptoms, use of health services, demographic and psychosocial characteristics, and quality of life.
Strengths And Weaknesses Of The Study Design And Database: MACS has experienced a high retention rate, with loss to follow-up of less than 20 percent among HIV positive men after ten years. MACS represents a repository of clinical specimens that cover the natural history of HIV infection and disease among a large cohort of at-risk individuals. The cohort has a disproportionately low number of minority homosexual and bisexual men participating. The MACS cohort also is not generalizable to segments of the newly HIV positive population who tend to have become HIV positive through injecting drug use or heterosexual transmission. The MACS cohort also is not generalizable to HIV positive women, a rapidly growing segment of the HIV positive population.
Gaps In The Data Collected And Factors Leading To The Gaps: None identified
Feasibility Of Linking With Other Databases: Feasibility is unclear. Public use tapes of accumulated MACS data are created biannually.
Process To Access The Database And Contact Person: Public use tapes may be obtained from NTIS. To order call (800) 553-6847 or through the NIAID website: http://www.niaid.nih.gov/research/aidsdata.htm.
Selected Citations:
Lyles RH, Tang AM, Smit E, Mellors JW, et al. Virologic, immunologic, and immune activation markers as predictors of HIV-associated weight loss prior to AIDS. JAIDS. 22(4): 386-394, 1999.
Saah AJ, Hoover DR, Peng Y, Phair JP, et al. Predictors of failure of Pneumocystis carinii pneumonia prophylaxis. JAMA. 273(15): 1197-1202, 1995.
Palenicek JP, Graham NMH, He YD, Hoover DA, et al. Weight loss prior to clinical AIDS as a predictor of survival. Journal of AIDS and Human Retrovirology. 10(3): 366-373, 1995.
Hoover, DR, Rinaldo C, He Y, Phair J, et al. Long-term survival without clinical AIDS after CD4+ cell counts fall below 200X106/I. AIDS. 9:145-152, 1995.
Kirby AJ, Munoz A, Detels R, Armstrong JA, et al. Thrush and fever as measures of immunocompetence in HIV-1-Infected men. Journal of AIDS and Human Retrovirology. 7(12): 1242-1249, 1994.
Kass NE, Munoz A, Chen B, Zucconi SL, Bing EG, et al. Changes in employment, insurance, and income in relation to HIV status and disease progression. JAIDS. 7(1): 86-91, 1994.
Bacellar H, Munoz A, Hoover DR, et al. Incidence of clinical AIDS conditions in a cohort of homosexual men with CD4+ cell counts less than 100/mm3. Journal of Infectious Diseases. 170:1284-1287, 1994.
Munoz A, Schrager LK, Bacellar H, et al. Trends in the incidence of outcomes defining acquired immunodeficiency syndrome (AIDS) in the Multicenter AIDS Cohort Study. American Journal of Epidemiology. 137: 423-438, 1993.
National Institute for Child Health and Human Development (NICHD)
Purpose Of The Database And Study Design: The REACH Project is designed to gain a better understanding of HIV disease progression and co-morbidity in adolescents to improve their health care management. Clinical science investigators participating in REACH must document two years experience caring for youth and must be affiliated with a clinical setting providing a wide array of adolescent health services to HIV positive youth. A total of 16 clinical sites in 13 cities participate in REACH, four sites in the New York/New Jersey area, three sites in the Mid-Atlantic area, six sites in the Southeast, one in Chicago, and one in Los Angeles.
Nature Of The Data Collected: A case-control design with HIV positive and uninfected sexually active adolescent study subjects is used. Longitudinal person-based clinical specimens, physical examination, and interview data are collected.
Unit Of Analysis: HIV positive and uninfected adolescent study subjects
Data Collection Methods: Several forms are used to collect data: direct face-to-face interviews, interactive computer interviewing (ICI), medical record abstraction, physical examination, and laboratory examination. Cases and controls are seen every three months, with data collected at each visit using all the data collection instruments except the ICI. The ICI is conducted every six months. Clinical investigators recruit study subjects at their clinical sites. Study coordinators are usually research nurses who have been centrally trained on both interviewing technique, as well as the intent of the questions. Clinicians and study coordinators are trained in protocol procedures, sample collection and processing, oral and skin examinations, and skinfold measurements.
General Attributes: Data gathered through the August 1997 database include baseline data on 225 subjects for the first 18 months of study accrual. Study recruitment and data collection are ongoing.
Major Data Constructs And Key Data Elements: Face-to-face interview measures include: demographic and educational characteristics, insurance coverage, living situation, and income, as well as a health history. The ICI gathers information regarding social support systems, depression, life-change events, HIV disclosure, coping, and sexual and drug-related behaviors. The physician examination includes standard measures, as well as the Tanner staging for sexual maturity, a gynecological and urogenital examination, and tuberculin test. Laboratory examinations include immunologic, virologic, hormonal, urinary drug screen, and sexually transmitted disease testing. A cerviocography is also conducted. The health-risk profile at entry into REACH includes a sexual history, condom use, smoking habits, and drug use. HIV testing, CD4 testing for HIV positive subjects, history of AIDS-related conditions, and use of antiretroviral treatment are also assessed at entry.
Strengths And Weaknesses Of The Study Design And Database: REACH is a well-established and documented cohort of HIV positive and uninfected adolescents.
Gaps In The Data Collected And Factors Leading To The Gaps: None identified.
Feasibility Of Linking With Other Databases: Linkage may be feasible with the consent of the study subjects.
Process To Access The Database And Contact Person: Audrey Rogers, PhD, NICHD, (301) 435-6873.
Selected Citations:
Rogers AS, Futterman DK, Moscicki AB, Wilson CM, et al. The REACH Project of the Adolescent Medicine HIV/AIDS Research Network: design, methods, and selected characteristics of participants. Journal of Adolescent Health. 22(4): 300-311, 1998.
Rogers AS, Futterman DK, Levin L, D’Angelo L. A profile of human immunodeficiency virus-infected adolescents receiving health care services at selected sites in the United States. Journal of Adolescent Health. 19(6): 401-408, 1996.
NIAID, in collaboration with National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI), National Institute on Dental Research and the CDC
Purpose Of The Database And Study Design: The WIHS is a multi-center, prospective study established in 1993 to carry out comprehensive investigations of the impact of HIV disease in women. WIHS was established in 1993 in tandem with a similar study, the HIV Epidemiology Research Study (HERS) coordinated by the CDC. The six WIHS sites are organized as a consortium. The sites are located in New York (two sites), the District of Columbia, Chicago, San Francisco, and Los Angeles. NIAID, NICHD, NIDA, NCI, and NIDR support various components of WIHS.
Nature Of The Data Collected: Longitudinal collection of physical examination, clinical specimen, and interview data
Unit Of Analysis: Study subjects are followed longitudinally
Data Collection Methods: Study subjects were recruited from HIV primary care clinics, hospital-based programs, and a variety of other community-based programs. To participate in WIHS, women must have been at least 13 years of age, provide informed consent to participate, be tested for HIV, complete an interview, participate in a baseline visit, and provide blood for laboratory testing. Study subjects participate in a baseline visit and follow-up visits every six months conducted by interviewers and examiners trained centrally. The baseline visit includes a physician and gynecological examination, oral examination, tuberculin and anergy skin testing, and laboratory specimen collection. Their medical records are also abstracted for all hospitalizations and HIV-related conditions.
General Attributes: A total of 2,641 women (2,066 HIV positive and 575 seronegative women) are under follow-up.
Major Data Constructs And Key Data Elements: The baseline visit interview gathers data regarding: demographic characteristics, medical and health history, obstetric and gynecologic history, drug use, sexual behavior, health care use, and psychosocial measures including quality of life. A baseline medical and gynecologic examination is conducted also. Similar data are collected at six-month intervals.
Strengths And Weaknesses Of The Study Design And Database: The generalizability of the groups studied is unclear.
Gaps In The Data Collected And Factors Leading To The Gaps: None identified
Feasibility Of Linking With Other Databases: Feasibility is unclear
Process To Access The Database And Contact Person:
Selected Citations:
Cejtin HE, Komaroff E, Massad LS, Korn A, et al. Adherence to colposcopy among women with HIV infection. JAIDS. 22(3): 247-252, 1999.
Weber K, Cohen M, Riester K, Holman S, et al. HIV research and women: what influences attrition? International Conference on AIDS. 12: 813 (Abstract No. 42202), 1998.
Ohmit S, Schuman P, Schoebbaum E, Rompaolo A, et al. Adherence to antiretroviral therapy (ART) among women in the HIV Epidemiology Research Study (HERS) and Women’s Inter-Agency HIV Study (WIHS). International Conference on AIDS. 12: 590 (Abstract No. 32347), 1998.
Levine AM, Melnick SL, Preston-Martin S, Silver S, et al. Use of mammography screening by HIV infected women: Women’s Interagency HIV Study (WIHS). International Conference on AIDS. 12: 590 (Abstract No. 32347), 1998.
Kovacs A, Chan L, Bremer J, Meyer WA, et al. Impact of plasma RNA on CD4 change and outcome for women in the Women’s Interagency HIV Study. International Conference on AIDS. 12: 803 (Abstract No. 42153), 1998.
Currier J, Richardson J, Masari L, Levine AM. Prevalence and determinants of non-use of antiretroviral therapy among women: Women’s Interagency HIV Study (WIHS). International Conference on AIDS. 12: 831 (Abstract No. 42288), 1998.
NIAID, in collaboration with NICHD and NIDA
Purpose Of The Database And Study Design: WITS is a multi-site collaborative longitudinal study of US HIV positive women and their offspring. Inner-city women, children, and drug users are the particular focus of WITS and WITS II. Almost one-half (45 percent) of WITS/WITS II subjects are African-American and 37 percent are Hispanic. Study sites include: Brigham and Children’s Hospital, University of Illinois at Chicago, Columbia University, the State University of New York (SUNY) Brooklyn, and Baylor University in Houston. Enrollment sites include Chicago, Boston, New York City, and San Juan. Enrollment was initiated in 1989 to determine risk factors for perinatal transmission and disease progression. This initiative supports longitudinal clinical, virologic, and immunologic evaluations, as well as an extensive repository of maternal and infant blood specimens. WITS currently focuses on several critical topics in perinatal HIV research including: factors contributing to perinatal HIV transmission, pathogenic aspects of primary HIV infections in infants, early immunologic and viral markers of rapid versus more stable disease progression, role of maternal drug use on transmission risk and disease progression, and assessment of evidence for or against potential immune response to HIV exposure among uninfected infants, as well as the effects of perinatal exposure to antiretrovirals.
Nature Of The Data Collected: Data collection has been conducted in two phases. In the first phase (1990 to 1993), three cohorts were enrolled: HIV positive pregnant women, their infants, and HIV positive non-pregnant women. In the second phase (1983 to present), HIV positive pregnant women and their infants were enrolled.
Unit Of Analysis: Longitudinal collection of clinical specimen, physical examination, and interview data
Data Collection Methods: Not available
General Attributes: About 1,800 pregnant women and 1,400 infants have enrolled.
Major Data Constructs And Key Data Elements: Adult specimens include blood and genital samples. Laboratory specimens are obtained from subjects at specified times throughout the study period. The content and timing of the laboratory testing varies depending upon the subject’s status (i.e., whether a woman or a child), the mother’s pregnancy status, and gestation at the time of enrollment.
Strengths And Weaknesses Of The Study Design And Database: None identified
Gaps In The Data Collected And Factors Leading To The Gaps: None identified
Feasibility Of Linking With Other Databases: No information provided
Process To Access The Database And Contact Person:
Selected Citations:
Hanson IC, Antonelli TA, Sperling RS, Oleske JM, et al. Lack of tumors in infants with perinatal HIV-1 exposure and fetal/neonatal exposure to zidovudine. Journal of AIDS and Human Retrovirology. 20(5): 463-367, 1999.
Rich KC, Siegal JN, Leurgans SE, Landay AL. Induced beta-chemokine and cytokine response in pregnant HIV-1 infected women and risk of perinatal transmission. International Conference on AIDS. 12: 397 (Abstract No. 23279), 1998.
Pacheco-Acosta E, Antonella T, Higgins A, Moroso NG, et al. Reproductive choices in the Women and Infant Transmission Study (WITS): pre and post ACTG 076 results. International Conference on AIDS. 12: 198 (Abstract No. 13565), 1998.
McIntosh K, FitzGerald G, Pitt J, Bremer JW, et al. A comparison of peripheral blood coculture versus 18- or 24-month serology in the diagnosis of human immunodeficiency virus infection in the offspring of infected women: Women and Infants Transmission Study. Journal of Infectious Disease. 178(2): 560-563, 1998.
Kalish LA, Diaz C, Rick KC, Shearer WT, et al. Virologic, immunologic, and clinical indicators of disease progression in a perinatal HIV cohort: the Women and Infants Transmission Study (WITS). International Conference on AIDS. 12: 160 (Abstract No. 13368), 1998.
Diaz C, Hanson C, Cooper ER, Read JS, et al. Disease progression in a cohort of infants with vertically acquired HIV infection observed from birth: the Women and Infant Transmission Study (WITS). Journal of AIDS and Human Retrovirology. 18(3): 221-228, 1998.
Cowles MK, Palumbo P, Virus detection, virus load, and disease progression in perinatally infected infants. . International Conference on AIDS. 12: 160-161 (Abstract No. 13369), 1998.
Kalish LA, Pitt J, Lew J, et al. Defining the time of fetal or perinatal acquisition of human immunodeficiency virus type 1 infection on the basis of age at first positive culture: Women and Infant Transmission Study (WITS). Journal of Infectious Disease. 175(3): 712-175, 1997.
Pitt J, Henrard D, Fitzgerald G, Lew J. et al. Association of HIV-1 antibodies (Ab) and ICD p24 antigen (Ag) with perinatal HIV-1 transmission. Conference on Retroviruses and Opportunistic Infections. 158 (Abstract No. 505), 1997.
Hanson IC, Pitt J, McIntosh K, Sherrieb K, et al. Standardized assessment of infants with indeterminate (IND) HIV-infection status followed in the Women and Infants Transmission Study (WITS). International Conference on AIDS. 11(2): 87 (Abstract No. We.B.3176), 1996.
Cooper ER, Hanson C, Diaz C, Abboud R, et al. Encephalopathy and HIV disease progression in a cohort of children with perinatally acquired HIV infection: the Women and Infants Transmission Study (WITS). International Conference on AIDS. 11(2): 26 (Abstract No. We.B.313), 1996.
Brambilla D, Leung S, Lew J, Shapiro D, et al. Interkit differences in plasma HIV-1 RNA levels in mothers enrolled in WITS/ACTG 076. Conference on Retroviruses and Opportunistic Infections. 178 (Abstract No. 616), 1997.
| [Health Resources and Services Administration, HIV/AIDS Bureau] | [Table of Contents] | [Substance Abuse and Mental Health Administration] |