Women & HIV/AIDS

Research and Clinical Trials

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• Women's Interagency HIV Study
• Clinical Trials
• Microbicide Research
• Vaccine Research
• Additional Resources

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.

• The more children an HIV-positive woman has living at home, the less likely she is to follow her HIV treatment plan compared to childless women with HIV.
• Women infected with HIV have a higher waist-to-hip ratio but lower BMI and smaller waist size than women who do not have HIV. Whether these findings affect heart disease risk is still not known. In general, carrying excess weight around the middle increases a woman’s heart disease risk, while a lower BMI lowers heart disease risk.
• 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 four popular HIV/AIDS clinical trial groups.

• Adult 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.

• International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT)
  IMPACT works to evaluate treatment for HIV-infected children, adolescents, and pregnant women. It works to develop and evaluate safe and effective approaches to prevent passing HIV from mother to child. It also works to evaluate vaccines for the prevention of HIV sexual transmission among adolescents.

• Community Programs for Clinical Research on AIDS (CPCRA)
  The CPCRA is a clinical trials program that conducts research in primary care settings through a national network of community-based clinical units. Together, the collaborating sites have enrolled more than 35,000 HIV-infected individuals in 47 clinical trials. Participating sites include private physicians' practices, public hospital clinics, freestanding community clinics, university and veterans' hospital clinics, and drug-treatment facilities. The results of CPCRA studies have significantly improved the care of people with HIV disease and AIDS.

• 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 sites in the United States, as well as overseas in Africa, Asia, Europe, and South America.

Microbicide Research

A topical microbicide (meye-KROH-buh-syd) is a gel, cream, or foam that is applied in the vagina or rectum before sex to prevent HIV and other STIs. These products would be nonirritating and inexpensive. Some experts think microbicides might be more successful than condoms in preventing HIV infection because they would be easier to use and women could use them without having to convince their partners, as they sometimes must do with condoms.  

• 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

Vaccine Research

Defeating HIV/AIDS will be hard — if not impossible — without a safe and effective vaccine. So, vaccine research has been and continues to be a top priority of NIH. Two different types of vaccines are being explored:

• Preventive vaccines are for people who are HIV-negative; they would be used to protect people from becoming infected with HIV.
• Therapeutic vaccines are for people who are HIV-positive; they would strengthen the immune system to prevent the progression of HIV to AIDS.

Additional Resources:

Publications

1.   Challenges in Designing HIV Vaccines — This publication gives an overview of the challenges involved in making an HIV vaccine. It provides 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 Trials Databases — This Internet site from the National Institutes of Health provides regularly updated information about federally and privately supported clinical research. It also gives information about a trial’s purpose, participants, location, and contact information.

   http://clinicaltrials.gov

3.   Clinical Trials of Medical Treatments: Why Volunteer? — This publication encourages people, including minorities and women, to participate in clinical trials and explains the benefits of doing so.

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

4.   HIV/AIDS Vaccines — This web site provides a comprehensive overview of HIV/AIDS vaccine research and development.

   http://www3.niaid.nih.gov/topics/HIVAIDS/Research/vaccines/default.htm

5.   Topical Microbicides Research — This report provides readers with current research activities that are underway on topical microbicides. It also provides other resources for more information on microbicide research.

   http://www3.niaid.nih.gov/topics/HIVAIDS/Research/prevention/research/Microbicides/research.htm...

6.   Vaccine Development — This online publication provides an overview of HIV vaccine development and evaluation.

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

7.   VRC Vaccine Research Studies — Healthy people are needed to help researchers evaluate vaccines against diseases, such as HIV/AIDS. This publication provides steps for how you can participate in a vaccine research study.

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

8.   What is an AIDS Clinical Trial? — This publication explains what AIDS clinical trials are, benefits and risks of clinical trials, questions to ask your doctor about participating, and where to get more information.

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

9. About Microbicides (Copyright © GCM) — This publication discusses the possible use of microbicides to prevent HIV and other sexually transmitted infections.

   http://www.global-campaign.org/about_microbicides.htm

10. Other Antiretroviral Drugs in Development (Copyright © AIDSInfoNet) — This publication discusses new antiretroviral drugs that are in development for treatment of HIV/AIDS, including gene therapies, intergrase inhibitors, and maturation inhibitors. This publication also links to fact sheets on specific classes of HIV medicines.

    http://www.aidsinfonet.org/fact_sheets/view/470?lang=eng

Organizations

1.   AIDS.gov
2.   AIDSinfo
3.   Centers for AIDS Research
4.   Centers for Disease Control and Prevention, HHS
5.   Division of Acquired Immunodeficiency Syndrome (DAIDS), NIAID, NIH, HHS
6.   Office of Rare Diseases Research, OD, NIH, HHS
7.   Office of Special Health Issues, FDA, OPHS, HHS
8. AIDS Community Research Initiative of America
9. ClinicalTrials.gov
10. Global Campaign for Microbicides
11. Project Inform
12. The HIV Vaccine Trials Network
13. UCSF Center for HIV Information (CHI)

= Indicates Federal Resources

Content last updated March 4, 2009.