CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,682 target
Drug / intervention
Acyclovir +1 moredrug
Likely dose
Acyclovir 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00076232
NCT00076232Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Acyclovir for the Reduction of HIV Acquisition Among High-Risk HSV-2 Seropositive, HIV Seronegative Individuals

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jan 16, 2004·Updated Dec 30, 2010

In Brief

A Phase 3 clinical trial evaluating Acyclovir and Acyclovir placebo for HIV Infections and 2 related conditions. Completed, enrolled 3,682 participants across 3 sites.

Detailed Summary

Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM). Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, HIV Seronegativity, Herpes Genitalis
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 16, 2004
Enrollment StartApr 1, 2005
Primary CompletionJun 1, 2007
Study CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 22.5 years ago

Interventions

Acyclovirdrug

400 mg tablet taken orally twice daily

Acyclovir placebodrug

Oral tablet taken twice daily