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July 24, 2012

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QUESTIONS AND ANSWERS
The ASPIRE HIV Prevention Study


1.    What is the ASPIRE study?
 

ASPIRE (“A Study to Prevent Infection with a Ring for Extended Use”) is a large, multinational clinical trial designed to test the effectiveness and extended safety of a drug-infused vaginal ring for preventing HIV infection in women. Also known as MTN 020, the study aims to determine whether the HIV antiretroviral drug dapivirine can safely and effectively prevent HIV infection when continuously released in the vagina from a silicone ring replaced once every 4 weeks. The trial is part of ongoing research to develop a safe, effective and acceptable microbicide for women.

2.   What is a microbicide?
   

A microbicide is a form of HIV prevention applied topically inside the vagina or rectum. Vaginal microbicides have been formulated as a ring, gel or film. No microbicide has been approved for use outside of research studies.

In July 2010, the CAPRISA 004 study found that a vaginal microbicide gel containing the HIV drug tenofovir at 1% concentration demonstrated a 39 percent level of efficacy at preventing HIV infection when applied within 12 hours before and within 12 hours after sex.

In November 2011, an interim review of data from the VOICE study revealed that 1% tenofovir gel was no more effective than a placebo gel at preventing HIV infection among the study participants, who were asked to apply the gel once daily regardless of the timing or frequency of sexual acts.

3.   Who is participating in the ASPIRE study?
   

The ASPIRE study team plans to enroll approximately 3,476 HIV-uninfected women ages 18 to 45 who are sexually active but not pregnant.

4.   Who is funding and sponsoring ASPIRE study?
   

The National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH), all part of NIH, are funding the ASPIRE study.

The clinical trial is being sponsored by the International Partnership for Microbicides, which developed the dapivirine silicone vaginal ring and is providing it for this study.

5.   Who is conducting the ASPIRE study?
   

The ASPIRE study is being conducted by the Microbicide Trials Network, which is funded by NIAID with co-funding from NIMH and NICHD.

Leading the study are protocol chair Jared Baeten, M.D., Ph.D., associate professor of global health at the University of Washington in Seattle; and protocol co-chair Thesla Palanee, Ph.D., director of network trials at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa.

6.   When will the ASPIRE study take place?
   

The ASPIRE study is starting in July 2012, and results are expected in early 2015.

7.   Where will the ASPIRE study take place?
   

The ASPIRE study will take place at 17 clinical trial sites in five African countries, pending all necessary approvals:

  • Malawi—Blantyre and Lilongwe
  • South Africa—Cape Town, Durban/KwaZulu-Natal and Johannesburg
  • Uganda—Kampala
  • Zambia—Lusaka
  • Zimbabwe—Harare
8.   What is the study design?
   

The ASPIRE study is a multicenter, two-arm, randomized, double-blind, placebo-controlled Phase 3 clinical trial. Study participants will be assigned at random to receive a flexible silicone ring containing either 25 mg of dapivirine or no drug (a placebo ring). Neither the participants nor the study team will know who receives which type of ring. Staff will counsel participants to insert a new ring into the vagina once every 4 weeks for at least 12 months.

During monthly study visits, the women will receive HIV tests, pregnancy tests, condoms, counseling on how to reduce their risk of acquiring HIV and other sexually transmitted infections, and a new silicone ring. Any women who become infected during the study will discontinue using the vaginal ring microbicide and will be referred to local medical care and support services.

9.   How will the safety of study participants be ensured?
   

The safety of study participants is evaluated at multiple levels beginning with the clinical staff at each clinical research site. Clinical research teams perform thorough checks on the health, safety and welfare of participants at each study visit. Safety is also monitored by a team at the MTN statistical and data management center that assesses incoming reports on a daily basis as well as a protocol safety review team that provides monthly oversight. An independent Data and Safety Monitoring Board (DSMB) will carefully monitor participants’ safety and HIV status. A DSMB is an independent group composed of clinical research experts, statisticians, ethicists and community representatives that meets periodically during the study to review safety and efficacy data as it is gathered. (The study team does not have access to pivotal study data until the clinical trial ends.) The DSMB alerts the study team if anything appears to compromise the safety of study participants, if there is compelling evidence of effectiveness, or if it becomes clear that the study cannot answer one of the questions it was designed to address.

10.   Why is the ASPIRE study important?
   

The ASPIRE study is important because an effective vaginal ring microbicide could give women a discreet, long-acting HIV prevention method they control. This would be particularly helpful in situations where it is difficult or impossible for women to refuse sex or to negotiate male condom use with their sexual partners. Women make up half of all people worldwide living with HIV, and in sub-Saharan Africa, women represent nearly 60 percent of adults living with the virus. In most cases, women become infected with HIV through sex with an infected male partner.

In addition, if the dapivirine vaginal ring is found to be effective, it could expand the number of HIV prevention tools available to curb the HIV/AIDS pandemic. The best offense against HIV infection is a comprehensive prevention toolkit that can be tailored to meet the needs of specific populations.

More information about the ASPIRE study is available at clinicaltrials.gov under study identifier NCT01617096 and on the MTN website.

Media inquiries can be directed to the NIAID Office of Communications at 301-402-1663, niaidnews@niaid.nih.gov.


NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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Last Updated July 21, 2012

Last Reviewed July 21, 2012