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NCT00074581 · ClinicalTrials.gov registry record · Phase 3

Preventing Sexual Transmission of HIV With Anti-HIV Drugs

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

Completed
Registry status
Phase 3
Development phase
3,526
Enrollment target

NCT00074581: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00074581 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 3,526 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (357% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00074581, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
3,526 participants
Enrollment target

Study Summary

This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.

Primary Outcome

incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.

Interventions

  • DRUG Lamivudine
  • DRUG Atazanavir
  • DRUG Efavirenz
  • DRUG Didanosine
  • DRUG Emtricitabine/Tenofovir disoproxil fumarate

Trial Details

FieldValue
Enrollment Target 3,526 participants
Start Date 2005-02
Est. Completion 2015-05
Phase Phase 3

What the finished NCT00074581 record still lists

NCT00074581 is an interventional study that assigns participants to a tested intervention. Its 3,526 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 (357% higher).

The record links to 0 conditions, and to 5 interventions - of which Lamivudine is the first listed.

NCT00074581 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00074581 about?

NCT00074581 is a clinical study titled "Preventing Sexual Transmission of HIV With Anti-HIV Drugs". This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.

What is the current status of trial NCT00074581?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,526 participants. The study started on 2005-02. Estimated completion is 2015-05.

What interventions are being tested in trial NCT00074581?

The interventions under investigation include: Lamivudine (DRUG), Atazanavir (DRUG), Efavirenz (DRUG), Didanosine (DRUG), Emtricitabine/Tenofovir disoproxil fumarate (DRUG).

Who is sponsoring clinical trial NCT00074581?

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 NCT00074581's enrollment target sits among peer trials

3,526 68th of 2000 higher than 1,933 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 NCT00074581, the US trial registry maintained by the National Library of Medicine. NCT00074581 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.