Corporate Banner
Satellite Banner
Immunology
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Daily-use HIV Prevention Approaches Prove Ineffective Among Women in NIH Study

Published: Tuesday, March 05, 2013
Last Updated: Monday, March 04, 2013
Bookmark and Share
Results likely due to very low levels of product use with young, single women least likely to use strategies.

Three antiretroviral-based strategies intended to prevent HIV infection among women did not prove effective in a major clinical trial in Africa.

For reasons that are unclear, a majority of study participants - particularly young, single women - were unable to use their assigned approaches daily as directed, according to findings presented by one of the study's co-leaders at the Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.

The Vaginal and Oral Interventions to Control the Epidemic (VOICE) study, or MTN 003, was designed to evaluate the safety and efficacy of three HIV prevention strategies compared to placebo.

The trial tested an investigational vaginal gel containing the antiretroviral drug tenofovir, a pill form of tenofovir (brand name Viread), and a pill containing a combination of tenofovir and emtricitabine (brand name Truvada).

The study was sponsored and largely funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

In the trial, the three strategies were tested among 5,029 sexually active women 18 to 45 years of age at 15 sites in South Africa, Uganda and Zimbabwe.

Nearly half of the study participants were under the age of 25, and most were unmarried (79 percent).

Participants in each of the three groups were counseled to use their assigned pill or gel once daily and received free condoms, ongoing counseling on how to reduce their HIV risk, and testing and treatment for sexually transmitted infections.

Prior to enrollment, all potential study participants engaged in an oral and written consent process explaining the details of the study.

Study results presented indicate that most VOICE participants did not adhere to the daily use schedule.

Moreover, single women 25 years of age and younger were the least likely to use the investigational products and the most likely to become infected with HIV.

The rate of new HIV infections among these young women was nearly 10 percent at some of the study sites in South Africa, reflecting a very high incidence of HIV infection among young women in these communities.

"We do not know why many participants in the VOICE study did not adhere to daily use of these HIV prevention strategies," said NIAID Director Anthony S. Fauci, M.D.

Fauci continued, "We must continue to conduct research to find additional HIV prevention tools that women will find acceptable and use consistently to protect themselves against infection."

In other HIV prevention studies involving different study populations, including men and women, both oral Truvada and oral tenofovir have demonstrated an ability to reduce the risk of HIV infection when used consistently.

However, the VOICE study results are consistent with another clinical trial known as the FEM-PrEP study, which tested daily use of oral Truvada among a similar population of women.

Like the VOICE study, researchers found that the majority of FEM-PrEP participants did not follow the daily regimen.

The VOICE study, which launched in 2009, was led by co-investigators Zvavahera Mike Chirenje, M.D., of the University of Zimbabwe in Harare, and Jeanne Marrazzo, M.D., M.P.H., from the University of Washington, Seattle.

In fall 2011, oral tenofovir (http://www.niaid.nih.gov/news/newsreleases/2011/Pages/VOICEmodified.aspx) and tenofovir vaginal gel (http://www.niaid.nih.gov/news/newsreleases/2011/Pages/VOICEdiscontinued.aspx) were dropped from the VOICE trial after separate routine reviews of the study data by an independent data and safety monitoring board determined that while each product was safe, neither was effective in preventing HIV compared with placebo.

Researchers continued to evaluate oral Truvada until the study's scheduled conclusion in August 2012. Results presented today at the CROI meeting by Dr. Marazzo provided an analysis for each of the study's three product arms.

Of the 5,029 women who enrolled in the VOICE study, 312 became infected with HIV for an overall 5.7 percent rate of new HIV infections - reflecting a very high overall rate of infection among women in these areas.

Twenty-two women were found to be HIV-infected at time of enrollment; therefore, the study's primary analysis was based on 5,007 participants.

There was no statistically significant difference in the rate of new infections between women assigned to the three investigational products and women using placebo. Among the 994 women who were assigned to daily use of Truvada, 61 women became infected with HIV (4.7 percent rate of new infections) compared with 60 of 1,008 women who became infected in the oral placebo group (4.6 percent rate of new infections).

Of the 1,002 participants in the daily oral tenofovir group, 60 women acquired HIV. However, the rate of new HIV infections was calculated to reflect what had occurred up until Oct. 3, 2011, when study sites began informing participants that testing of oral tenofovir would end.

At this time, 52 women acquired HIV (6.3 percent rate of new infections) compared with 35 of 1,008 women who became infected in the placebo arm (4.2 percent rate of new infections). Of the 1,003 women assigned to use daily tenofovir gel, 61 became infected with HIV (5.9 percent rate of new infections), and 70 infections occurred among the 1,000 women in the placebo gel group (6.8 percent rate of new infections).

Women who became infected with HIV during the VOICE study were referred to local sites for appropriate medical care and treatment.

During the course of the study, adherence to each of the three approaches was anticipated to be roughly 90 percent based on what study participants reported to clinic site staff and monthly counts of unused gel applicators and leftover study pills that were returned to the sites.

However, in a blood sample analysis of 773 participants, including 185 participants who became HIV-infected, it became clear that adherence was low across each of the study's three investigational product groups.

Drug was detected in the blood of 29 percent of the women in the Truvada group, 28 percent in the oral tenofovir group and 23 percent among those in the tenofovir gel group. When examining the data by age, young, single women were less likely to use their assigned treatment strategy.

For example, among the women assigned to use oral Truvada, drug was detected in the blood of only 21 percent of young, single women compared to 54 percent of those married and over the age of 25.

"Based on our findings, it is clear that young, single women in Africa continue to be at very high risk for HIV infection and may need the greatest assistance with using prevention strategies consistently," said Dr. Marrazzo. Among VOICE study participants, the rate of new HIV infections was nearly 9 percent among unmarried women under the age of 25 compared to 0.8 percent for older married women, a statistically significant difference.

Through two ongoing behavioral studies involving VOICE participants, researchers are hoping to gain insight as to why the women did or did not use the investigational products. Results from those two studies are expected later this year.

NIAID funded the VOICE study with co-funding from the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, also part of the NIH.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Researchers Find a Gap in the Brain’s Firewall Against Parkinson’s Disease
Researchers at NIH have found mouse study that identified a key player in the progression of the disorder.
Saturday, October 01, 2016
Oxygen Can Impair Cancer Immunotherapy
Researchers have identified a mechanism within the lungs where anticancer immune resposnse is inhibited.
Friday, August 26, 2016
New Inflammatory Disease Discovered
NIH researchers have discovered a rare and potentially deadly disease - otulipenia - the mostly affects children.
Tuesday, August 23, 2016
Oral Immunotherapy Is Safe, Effective Treatment for Peanut-Allergic Preschoolers
Study demonstrates the potential of peanut OIT to suppress allergic immune responses to peanut.
Friday, August 12, 2016
Mutations Linked to Immunotherapy Resistance
Researchers uncover mutations in tumors of three patients with advanced melanoma that allowed the tumors to become resistant to the immune checkpoint inhibitor pembrolizumab (Keytruda®).
Tuesday, August 09, 2016
Zika Vaccine Candidates Show Promise
Two experimental vaccines have shown promise against a major viral strain responsible for the Brazilian Zika outbreak.
Friday, July 29, 2016
Targeting Autoimmunity
Researchers have developed a strategy to treat a rare autoimmune disease which could lead to treatments of other autoimmune diseases.
Wednesday, July 27, 2016
NIH Investment Into HIV Research Expands
Funding has been awarded to six research teams to lead collaborative investigations worldwide toward an HIV cure.
Thursday, July 14, 2016
Drug Might Help Treat Sepsis
A DNA enzyme called Top1 plays a key role in turning on genes that cause inflammation in mouse and human cells in response to pathogens. A drug blocking this enzyme rescued mice from lethal inflammatory responses, suggesting a potential treatment for sepsis.
Wednesday, May 18, 2016
Large-scale HIV Vaccine Trial to Launch in South Africa
NIH-funded study will test safety, efficacy of vaccine regimen.
Wednesday, May 18, 2016
New HIV Vaccine Target Discovered
NIH-Led team have discovered a new vaccine target site on HIV.
Tuesday, May 17, 2016
Finding Factors That Protect Against Flu
A clinical trial examining the body’s response to seasonal flu suggests new approaches for evaluating the effectiveness of seasonal flu vaccines.
Wednesday, April 27, 2016
Factors Influencing Influenza Vaccine Effectiveness Uncovered
The long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited, new research suggests.
Thursday, April 21, 2016
Study Finds Factors That May Influence Influenza Vaccine Effectiveness
Researchers at NIH have suggested that the long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited.
Wednesday, April 20, 2016
Submissions Open for the Cancer Moonshot Program
NCI opens online platform to submit ideas about research for Cancer Moonshot.
Tuesday, April 19, 2016
Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Researchers Find a Gap in the Brain’s Firewall Against Parkinson’s Disease
Researchers at NIH have found mouse study that identified a key player in the progression of the disorder.
Faecal Bacteria Linked to Body Fat
Researchers at King’s College London have found a new link between the diversity of bacteria in human poo – known as the human faecal microbiome - and levels of abdominal body fat.
‘Cellbots’ Chase Down Cancer, Deliver Drugs Directly to Tumors
Programmable T cells shown to be versatile, precise, and powerful in lab studies.
Anti-Inflammatory Drugs Could Strengthen Airway Immunity
Mold toxins can weaken the airways' clearing mechanisms and immunity, but PKC inhibitors showed promise as a treatment.
Antibodies Paving the Way to HIV Vaccine
Researchers uncover factors responsible for the formation of broadly neutralizing HIV antibodies in humans.
Vaccine Against Common Cold Achievable
Researchers suggest that a vaccine against rhinoviruses is possible using variant virus vaccines.
Iron Nanoparticles Make Immune Cells Attack Cancer
Researchers accidentally discover that nanoparticles invented for anemia treatment can trigger the immune system’s ability to destroy tumor cells.
Uncovering Cancer’s ‘Invisibility Cloak’
Researchers discover cancer cell mechanism to become invisible to the body's immune system.
Treating Sepsis with Marine Mitochondria
Mitochondrial alternative oxidase from a marine animal combats bacterial sepsis.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!