Research and Clinical Trials

Home > HIV/AIDS Home > Research and Clinical Trials

• Women's Interagency HIV Study
• Clinical Trials
• Microbicide Research
• Vaccine Research
• Additional Information on Research and Clinical Trials

To confront the growing problem of HIV infection and AIDS in women, the National Institute of Allergy and Infectious Diseases (NIAID) has made research on women an important part of the Institute's AIDS research program.

Women's Interagency HIV Study

The Women's Interagency HIV Study, started in 1993, is designed to investigate the history and course of HIV infection in women. This nationwide study tracks 3,000 HIV positive women and 1,000 women without HIV but at high risk of getting the virus. About 80 percent of those in the study are minority women. Several findings from the study are listed below.

• Depression leads to lower T-cells and greater risk of death in HIV positive women. These findings point to depression as a risk factor for death for HIV positive people, both male and female.

• A look at HIV positive women found that vitamin A deficiency was associated with abnormal Pap smears, the first step towards cervical cancer.

• Active drug users who were HIV positive had a higher rate of death from non HIV causes. These included deaths from liver failure, murder, suicide, and overdose on illicit drugs.

Clinical Trials

Many areas of HIV/AIDS research involve clinical trials. Clinical trials are research studies designed to find out if new drugs, vaccines, or other treatments are safe and if they work. Sometimes, it can be hard for patients to learn about opportunities to take part in clinical trials. Doctors and patient advocacy groups can be great resources for patients looking for clinical trial information.

You can find out about HIV/AIDS clinical trials at the National Institutes of Health (NIH). You can also call the Vaccine Research Center of the NIH at 1-866-833-5433.

Newspapers, particularly in large cities, often carry clinical trial recruitment advertisements. A call to a nearby university medical center can also lead to information about clinical trials currently recruiting patients. If you decide to take part in a clinical study, see the CDC brochure to learn what questions you should ask. Below are three popular HIV/AIDS clinical trial groups.

• AIDS Clinical Trials Group (ACTG)
  ACTG, the largest HIV clinical trials organization in the world, plays a major role in setting standards of care for HIV infection and OIs related to HIV/AIDS in the United States and the developing world.

• Pediatric AIDS Clinical Trials Group (PACTG)
  PACTG evaluates treatment for HIV-infected children and teens, and for developing new approaches for understanding passing HIV from mother to child. Those most benefited by the PACTG includes underserved pregnant women, infants, children, and adolescents of diverse racial and ethnic backgrounds.

• HIV Prevention Trials Network (HPTN)
  NIAID established the HPTN in July 2000 as a global research network to evaluate the safety and value of non-vaccine prevention medicines, including topical microbicides. Research through the HPTN is carried out through HIV Prevention Trials Units (HPTUs) located at 15 sites in the United States in Alabama, California, Maryland, Massachusetts, New York, North Carolina, Pennsylvania, Washington;14 sites overseas in Africa, Asia, Europe, and South America are also included.

Microbicide Research

A topical microbicide is a gel, cream, or foam that is applied vaginally to prevent STDs such as HIV. Products undergoing research may work by:

• slowing down HIV
• blocking attachment of HIV to at-risk cells
• stopping viral spread from the first cells that acquire HIV to other cells in the body

In addition to products that can be applied vaginally, the program also is researching the possibility of using microbicides to prevent passing HIV during anal sex.

NIAID supports a wide variety of topical microbicide research programs. Below are completed NIAID-supported clinical trials.

• A domestic and international Phase I study of PRO2000/5 gel, a product that slows down HIV entry into the body. PRO2000/5 gel was found to be safe. Future studies will be planned.

• A Phase I safety study of an acid-buffering product that may reduce passing of STDs, including HIV, by maintaining the natural acidity (tartness/bitterness) of the vagina in the presence of seminal fluid. HIV negative, sexually abstinent and active women using the acid-buffering product, BufferGel, did not experience any serious side effects.

• An expanded Phase II safety study of a gel containing the spermicide, nonoxynol-9 (N-9), for vaginal use. No serious safety concerns were identified.

• A Phase I safety study of an N-9 containing gel for rectal use. No serious safety concerns were identified.

• A Phase III trial of an N-9 containing vaginal film. N-9 did not provide significant protection against the passing of HIV.

Vaccine Research

Research on ways to control AIDS remains a top priority for the NIH. HIV vaccines are a key component of this research because they could work in one of several ways:

• to prevent passing
• to prevent HIV infection
• to prevent the progression of HIV to AIDS

The AIDS Vaccine Research Working Group (AVRWG), formerly known as the AIDS Vaccine Research Committee or AVRC, assists the NIH in developing research aimed at speeding up the discovery and development of an HIV/AIDS vaccine. Below are the two different types of vaccines being researched.

• Preventive vaccines are for HIV negative individuals; they are to prevent HIV infection.
• Therapeutic vaccines are for HIV positive individuals; they are to strengthen the immune system.

If you are interested in participating in a trial or in getting involved in a local Community Advisory Board, select a trial site in a city near you and contact the site recruiter or community educator. If you would like to get more information about the HVTN community education program, email info@hvtn.org.

Additional Information on Research and Clinical Trials:

Publications

1.   Challenges in Designing HIV Vaccines - This publication gives an overview of the challenges involved in making an HIV Vaccine. It contains information on immune protection and response, regulatory T cells, HIV Strain Variation, immune system breakdown, and animal model studies.

   http://www.niaid.nih.gov/factsheets/challvacc.htm

2.   Clinical Studies: How to Volunteer - This online publication lists the steps involved in participating in the clinical study of an HIV vaccine.

   http://www.niaid.nih.gov/vrc/clintrials/clin_steps.htm

3.   Clinical Trials Databases - This Internet site from the National Institutes of Health provides regularly updated information about federally and privately supported clinical research. In addition it gives information about a trial’s purpose, participants, location, and phone numbers.

   http://clinicaltrials.gov

4.   Clinical Trials of Medical Treatments: Why Volunteer? - This online booklet encourages people, including minorities and women, to participate in clinical trials and some of the benefits from doing so.

   http://www.fda.gov/opacom/lowlit/cltr.html

5.   HIV/AIDS Vaccines - This web site provides a comprehensive overview of AIDS vaccine discovery and development.

   http://www3.niaid.nih.gov/research/topics/HIV/vaccines/

6.     Topical Microbicides Research - This report explains how microbicides could help women prevent HIV. It also discusses what an ideal microbicide would be like, and what is needed to support research and development of microbicides for HIV prevention.

   http://www3.niaid.nih.gov/healthscience/healthtopics/topicalmicrobicides/PDF/topi...

7.   Vaccine Development - This online publication provides links to information on HIV vaccine development and evaluation and other publications regarding this topic.

   http://www.cdc.gov/hiv/topics/research/vaccine_unit/development.htm

8.   What is an AIDS Clinical Trial? - This publication discusses AIDS Clinical Trials. It also explains what they are, what questions to ask your doctor about participating, and where to get more information.

   http://aidsinfo.nih.gov/ClinicalTrials/ClinicalTrial.aspx?menuItem=ClinicalTrials...

9.   What Is an HIV/AIDS Clinical Trial? - This fact sheet explains the protocol, risks, and benefits of participating in an HIV/AIDS clinical trial.

   http://www.aidsinfo.nih.gov/ContentFiles/WhatIsAClinicalTrial_FS_en.pdf

Organizations

1.   AIDS.Gov
2.   AIDSInfo
3.   Centers for AIDS Research
4.   Division of Acquired Immunodeficiency Syndrome(DAIDS), NIAID, NIH, HHS
5.   Office of Rare Diseases, OD, NIH, HHS
6.   Office of Special Health Issues, FDA, OPHS, HHS
7. AIDS Community Research Initiative of America
8. Center For AIDS Research at NYU School of Medicine
9. Clinicaltrials.gov
10. Project Inform
11. The HIV Vaccine Trials Network
12. Thomson Center Watch: Clinical Trials Listing Service
13. UCSF Center for HIV Information (CHI)

= Indicates Federal Resources

Content last updated January 25, 2008.