VOICE trial indicates daily dosing of tenofovir gel ineffective

November 25, 2011

Arlington, VA - An independent review of the VOICE study, funded by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted by the Microbicide Trials Network, determined that tenofovir gel was no more effective than placebo gel in preventing HIV. The review found no safety concerns and the VOICE study will continue to evaluate the effectiveness of the oral Truvada tablet in preventing HIV in women. It is unknown at this time why tenofovir gel did not work in this particular trial. The study will need to be completed before data can be analyzed to determine whether adherence to a daily regimen was possibly a key factor.

Use of tenofovir gel was shown to be effective in reducing HIV and herpes infections in the CAPRISA 004 study, which tested a different dosing strategy where women were asked to use the gel before and after sex. The CONRAD-sponsored FACTS 001 trial, which is currently assessing the same dosing regimen as the CAPRISA 004 trial, is ongoing in South Africa.

"Tenofovir gel is still a promising new product for women," said CONRAD Executive Director Dr. Henry Gabelnick. "Despite the disappointment of this result, VOICE will contribute important safety data toward the possible licensure of tenofovir gel. We are pleased that USAID, the Bill & Melinda Gates Foundation, and the government of South Africa are supporting the FACTS study, which will serve to provide confirmatory results for regulatory approval."

Gilead Sciences licensed tenofovir royalty-free to CONRAD, who manufactured and supplied the gel for the CAPRISA 004, VOICE and FACTS 001 trials. CONRAD and the South African Government's Technology Innovation Agency (TIA) have a license agreement that grants TIA the rights to manufacture and distribute tenofovir gel in Africa, pending regulatory approval.

If FACTS 001 can confirm CAPRISA's positive results, these combined effectiveness data, along with VOICE's safety data on tenofovir gel, may enable the licensure of the first microbicide for women, and a powerful new tool for women to protect themselves from HIV and genital herpes.
Information about VOICE, including a Questions and Answers document about the study can be found at http://www.mtnstopshiv.org/news/studies/mtn003 and a summary of recent trial results of other PrEP studies can be found at http://www.avac.org/ht/d/sp/i/326/pid/326

For more information on FACTS, please go to: www.facts-consortium.co.za

CONRAD was established in 1986 and is a Division of the Department of Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in Norfolk, VA, where it has laboratories and a clinical research center. The main office is located in Arlington, VA, and our scientists work with collaborators around the world. CONRAD is committed to improving reproductive health by researching and developing new contraceptive options and products to prevent HIV and STI infections. www.conrad.org.

Annette Larkin
703.772 6427


Related HIV Articles from Brightsurf:

BEAT-HIV Delaney collaboratory issues recommendations measuring persistent HIV reservoirs
Spearheaded by Wistar scientists, top worldwide HIV researchers from the BEAT-HIV Martin Delaney Collaboratory to Cure HIV-1 Infection by Combination Immunotherapy (BEAT-HIV Collaboratory) compiled the first comprehensive set of recommendations on how to best measure the size of persistent HIV reservoirs during cure-directed clinical studies.

The Lancet HIV: Study suggests a second patient has been cured of HIV
A study of the second HIV patient to undergo successful stem cell transplantation from donors with a HIV-resistant gene, finds that there was no active viral infection in the patient's blood 30 months after they stopped anti-retroviral therapy, according to a case report published in The Lancet HIV journal and presented at CROI (Conference on Retroviruses and Opportunistic Infections).

Children with HIV score below HIV-negative peers in cognitive, motor function tests
Children who acquired HIV in utero or during birth or breastfeeding did not perform as well as their peers who do not have HIV on tests measuring cognitive ability, motor function and attention, according to a report published online today in Clinical Infectious Diseases.

Efforts to end the HIV epidemic must not ignore people already living with HIV
Efforts to prevent new HIV transmissions in the US must be accompanied by addressing HIV-associated comorbidities to improve the health of people already living with HIV, NIH experts assert in the third of a series of JAMA commentaries.

The Lancet HIV: Severe anti-LGBT legislations associated with lower testing and awareness of HIV in African countries
This first systematic review to investigate HIV testing, treatment and viral suppression in men who have sex with men in Africa finds that among the most recent studies (conducted after 2011) only half of men have been tested for HIV in the past 12 months.

The Lancet HIV: Tenfold increase in number of adolescents on HIV treatment in South Africa since 2010, but many still untreated
A new study of more than 700,000 one to 19-year olds being treated for HIV infection suggests a ten-fold increase in the number of adolescents aged 15 to 19 receiving HIV treatment in South Africa, according to results published in The Lancet HIV journal.

Starting HIV treatment in ERs may be key to ending HIV spread worldwide
In a follow-up study conducted in South Africa, Johns Hopkins Medicine researchers say they have evidence that hospital emergency departments (EDs) worldwide may be key strategic settings for curbing the spread of HIV infections in hard-to-reach populations if the EDs jump-start treatment and case management as well as diagnosis of the disease.

NIH HIV experts prioritize research to achieve sustained ART-free HIV remission
Achieving sustained remission of HIV without life-long antiretroviral therapy (ART) is a top HIV research priority, according to a new commentary in JAMA by experts at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The Lancet HIV: PrEP implementation is associated with a rapid decline in new HIV infections
Study from Australia is the first to evaluate a population-level roll-out of pre-exposure prophylaxis (PrEP) in men who have sex with men.

Researchers date 'hibernating' HIV strains, advancing BC's leadership in HIV cure research
Researchers have developed a novel way for dating 'hibernating' HIV strains, in an advancement for HIV cure research.

Read More: HIV News and HIV Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.