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NCT00076232 · ClinicalTrials.gov registry record · Phase 3

A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes

A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
3,682
Enrollment target

NCT00076232: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00076232 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 3,682 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (377% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00076232, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
3,682 participants
Enrollment target

Study 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.

Interventions

  • DRUG Acyclovir
  • DRUG Acyclovir placebo

Trial Details

FieldValue
Enrollment Target 3,682 participants
Start Date 2005-04
Est. Completion 2007-11
Phase Phase 3

What the finished NCT00076232 record still lists

NCT00076232 is an interventional study that assigns participants to a tested intervention. Its 3,682 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (377% higher).

The record links to 0 conditions, and to 2 interventions - of which Acyclovir is the first listed.

NCT00076232 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00076232 about?

NCT00076232 is a clinical study titled "A Study of Acyclovir to Help Prevent HIV Infection in People With Genital Herpes". 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 ...

What is the current status of trial NCT00076232?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,682 participants. The study started on 2005-04. Estimated completion is 2007-11.

What interventions are being tested in trial NCT00076232?

The interventions under investigation include: Acyclovir (DRUG), Acyclovir placebo (DRUG).

Who is sponsoring clinical trial NCT00076232?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00076232's enrollment target sits among peer trials

3,682 66th of 2000 higher than 1,935 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00076232, the US trial registry maintained by the National Library of Medicine. NCT00076232 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.