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NCT00951015 · ClinicalTrials.gov registry record · Phase 2

A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects

A Phase 2 study, sponsored by ViiV Healthcare.

Completed
Registry status
Phase 2
Development phase
208
Enrollment target

NCT00951015: Completed Phase 2 study, sponsored by ViiV Healthcare.

NCT00951015 is a Phase 2 study that has completed, run by ViiV Healthcare. The registered enrollment target is 208 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00951015, a Phase 2 study, has completed, sponsored by ViiV Healthcare.

COMPLETED
Registry status
Phase 2
Development phase
208 participants
Enrollment target

Study Summary

This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.

Primary Outcome

Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (\<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they ha

Interventions

  • DRUG efavirenz
  • DRUG GSK1349572

Trial Details

FieldValue
Enrollment Target 208 participants
Start Date 2009-07-30
Est. Completion 2016-12-22
Phase Phase 2
ViiV Healthcare

182 total trials

What the finished NCT00951015 record still lists

NCT00951015 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% higher).

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

NCT00951015 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00951015 about?

NCT00951015 is a clinical study titled "A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects". This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.

What is the current status of trial NCT00951015?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 208 participants. The study started on 2009-07-30. Estimated completion is 2016-12-22.

What interventions are being tested in trial NCT00951015?

The interventions under investigation include: efavirenz (DRUG), GSK1349572 (DRUG).

Who is sponsoring clinical trial NCT00951015?

This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00951015's enrollment target sits among peer trials

208 294th of 2000 higher than 1,704 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00951015, the US trial registry maintained by the National Library of Medicine. NCT00951015 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.