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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000874 |
To determine the short-term virologic and immunologic effects of using plasma genotypic antiretroviral resistance testing (GART) results (interpreted by study virologists AS PER AMENDMENT 9/17/97) in the management of therapy for antiretroviral-experienced patients failing on one of the following regimens:
Condition |
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HIV Infections |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART |
Blood collection
Enrollment: | 148 |
Study Start Date: | August 1997 |
Primary Completion Date: | January 1999 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Participants who are failing a regimen of ZDV, 3TC, and IDV
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2
Participants who are failing a regimen of ZDV, 3TC, and SRQ
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3
Participants who are failing a regimen of ZDV, 3TC, and RTV
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4
Participants who are failing a regimen of d4T, 3TC, and IDV
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A growing body of evidence suggests that antiretroviral resistance is associated with an increased risk of disease progression and death. All commercially available antiretrovirals and many of those in development have been associated with resistance. Fortunately, techniques are available to define HIV genotypic resistance in "real time" as compared to techniques that measure phenotypic resistance that is not practical in a clinical setting. Using genotypic antiretroviral resistance testing (GART) results, along with other currently available markers, may lead to improved treatment decisions compared with using currently available markers alone.
128 patients are randomized to GART or no GART within each of four strata defined by current antiretroviral regimen:
[AS PER AMENDMENT 9/17/97: 128 patients are randomized to therapy based on GART results or therapy not based on these results. Patients are stratified into 8 groups defined by current antiretroviral regimen (ZDV/3TC/IDV vs. ZDV/3TC/SQV vs. ZDV/3TC/RTV vs. d4T/3TC/IDV) and screening CD4+ count (50-199 vs. 200-500). Management of patients assigned to the GART group is based on recommendations of study virologists after independent review of patient plasma GART results in addition to current clinical practice. Up to four different treatment regimens using only licensed drugs may be recommended, ranked but considered approximately therapeutically equivalent. The management of patients assigned to the no-GART group is based on current clinical practice and includes only licensed antiretrovirals.] [AS PER AMENDMENT 11/26/97: 160 patients are randomized to GART or no GART within each of 8 strata defined by current antiretroviral regimen (NRTI-1 plus NRTI-2 plus IDV vs. NRTI-1 plus NRTI-2 plus SQV vs. NRTI-1 plus NRTI-2 plus RTV vs. NRTI-1 plus NRTI-2 plus NFV) and screening CD4+ cell count.]
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
HIV-infected participants currently failing their antiretroviral regimens
Inclusion Criteria
Patients must have:
Prior Medication: Included:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
[AS PER AMENDMENT 11/26/97:
Patients must currently be on one of the following triple antiretroviral regimens for at least 16 weeks:
Concurent Treatment: Excluded:
United States, California | |
Community Consortium of San Francisco | |
San Francisco, California, United States, 94110 | |
Community Consortium / UCSF | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Denver CPCRA / Denver Public Hlth | |
Denver, Colorado, United States, 802044507 | |
VA Med Ctr | |
Denver, Colorado, United States, 802044507 | |
S Denver Infectious Diseases Specialists | |
Denver, Colorado, United States, 802044507 | |
Alpine Family Medicine / Janowski | |
Denver, Colorado, United States, 802044507 | |
United States, District of Columbia | |
Veterans Administration Med Ctr / Regional AIDS Program | |
Washington, District of Columbia, United States, 20422 | |
Montgomery County Health Dept | |
Washington, District of Columbia, United States, 204220001 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
AIDS Research Alliance - Chicago | |
Chicago, Illinois, United States, 60657 | |
United States, Louisiana | |
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
New Orleans, Louisiana, United States, 70112 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
Wayne State Univ / WSU / DMC HIV / AIDS Program | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
North Jersey Community Research Initiative | |
Newark, New Jersey, United States, 071032842 | |
Southern New Jersey AIDS Cln Trials / Dept of Med | |
Camden, New Jersey, United States, 08103 | |
Mercer Area Early Intervention Services | |
Camden, New Jersey, United States, 081031438 | |
United States, New Mexico | |
Partners Research | |
Albuquerque, New Mexico, United States, 871315271 | |
T A Ferrill Regional HIV Clinic | |
Albuquerque, New Mexico, United States, 871315271 | |
Partners in Research / New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
United States, New York | |
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
United States, Oregon | |
The Research and Education Group | |
Portland, Oregon, United States, 97210 | |
United States, Pennsylvania | |
Philadelphia FIGHT | |
Philadelphia, Pennsylvania, United States, 19107 | |
Saint Joseph's Hosp | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Virginia | |
Richmond AIDS Consortium | |
Richmond, Virginia, United States, 23298 |
Study Chair: | Baxter J | |
Study Chair: | Mayers D | |
Study Chair: | Merigan T |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | CPCRA 046 |
Study First Received: | November 2, 1999 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000874 |
Health Authority: | United States: Federal Government |
HIV-1 Drug Therapy, Combination Zidovudine Stavudine Drug Resistance, Microbial HIV Protease Inhibitors CD4 Lymphocyte Count Ritonavir |
Lamivudine Indinavir RNA, Viral Genotype Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Virus Diseases Sexually Transmitted Diseases, Viral Stavudine Indinavir Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lamivudine Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |