NIH Modifies VOICE HIV Prevention Study
“A large-scale clinical trial evaluating whether daily use of an oral tablet or vaginal gel containing antiretroviral drugs can prevent HIV infection in women is being modified because an interim review found that the study cannot show that one of the study products, oral tenofovir, marketed under the trade name Viread, is effective.
“An independent data and safety monitoring board (DSMB) recommended that the Vaginal and Oral Interventions to Control the Epidemic (VOICE) (http://www.niaid.nih.gov/news/newsreleases/2009/Pages/VOICE.aspx) study discontinue evaluating tenofovir tablets because the study will be unable to show a difference in effect between tenofovir tablets and placebo tablets. The DSMB found no safety concerns with oral tenofovir, which is currently used to treat HIV, or with the other products that will continue to be investigated as the VOICE study proceeds.
“As the trial's primary sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, concurred with the DSMB's recommendation and will modify the study. Because the trial is continuing, the study data remain confidential and restricted to DSMB analysis. Given that data are unavailable, NIAID cannot speculate about why oral tenofovir did not show an effect among VOICE study participants. …
“The study team will immediately begin to inform all VOICE participants of this new development and will soon begin the orderly discontinuation of the tenofovir tablets. Participants who were taking oral tenofovir will stop using the product at their next scheduled clinical site visit. They will then return eight weeks later for a final set of tests and procedures before exiting the study. At that visit, they will be provided information about where they can continue to receive HIV testing and counseling, contraception and other medical and support services.
“NIAID is pleased that the trial will continue to examine the question of whether tenofovir gel and oral Truvada are safe and effective HIV prevention measures for women and thanks all participants in the VOICE study for their significant contribution to furthering HIV prevention research.”
More information is available:
HHS Panel on Antiretroviral Guidelines for Adults and Adolescents Still Accepting Nominations for New Scientific/Clinical Members
The Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) is accepting nominations for new scientific/clinical members with expertise in HIV medicine. The Panel is seeking candidates with expertise in HIV clinical care and research who can critically evaluate new information and help prepare guideline revisions. Candidates for Panel membership shall be recognized experts in their areas of interest, with outstanding records of publication and presentation. Individuals from diverse backgrounds, those from underrepresented geographic areas, and women are strongly encouraged to apply.
Successful candidates will serve a 4-year term beginning March 2012, with potential for reappointment for a second term. Panel members are not compensated for their time commitment and travel support is generally not provided.
The Panel is a Working Group of the Office of AIDS Research Advisory Council of the National Institutes of Health. The Panel is composed of approximately 35 members who are clinicians, researchers, academicians, HHS representatives, and community representatives with expertise in HIV management in the United States. Panel members meet monthly via teleconference and annually in person to review and critically evaluate emerging scientific data relating to antiretroviral therapy and to revise the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. (To review the latest revision of the guidelines, which was published on January 10, 2011, visit the AIDSinfo Clinical Guidelines Portal.)
Please include with nominations the candidate’s curriculum vitae and a letter detailing how the nominee’s expertise would contribute to the work of the Panel. Self-nominations are welcome.
The deadline for nominations is October 14, 2011, and submissions can be e-mailed to Alice Pau, Pharm.D., at firstname.lastname@example.org or sent to the address below.
Alice K. Pau, Pharm.D., FIDSA
Executive Secretary, HHS Panel on Antiretroviral Guidelines for Adults and Adolescents
NIAID-NIH, Building 10, Room 11C103, MSC 1880
Bethesda, MD 20892