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NCT01102972 · ClinicalTrials.gov registry record · Phase 4
A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)
A Phase 4 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 4
- Development phase
- 297
- Enrollment target
NCT01102972: Completed Phase 4 study, sponsored by ViiV Healthcare.
NCT01102972 is a Phase 4 study that has completed, run by ViiV Healthcare. The registered enrollment target is 297 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01102972, a Phase 4 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 297 participants
- Enrollment target
Study Summary
This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B\*5701 negative subjects for 48 weeks.
Primary Outcome
The percentage of PAR with HIV-1 RNA virus \<50 c/mL determined from blood samples drawn at Week 24 was tabulated by treatment arm with stratification by initial antiretroviral treatment. Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/mL who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/mL, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/mL, or had a
Interventions
- DRUG Reyataz + Norvir + Truvada
- DRUG Reyataz + Epzicom
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
What the finished NCT01102972 record still lists
NCT01102972 is an interventional study that assigns participants to a tested intervention. The registered 297 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Reyataz + Norvir + Truvada is the first listed.
NCT01102972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01102972 about?
NCT01102972 is a clinical study titled "A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)". This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B\*5701 n...
What is the current status of trial NCT01102972?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 297 participants. The study started on 2010-04. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01102972?
The interventions under investigation include: Reyataz + Norvir + Truvada (DRUG), Reyataz + Epzicom (DRUG).
Who is sponsoring clinical trial NCT01102972?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01102972's enrollment target sits among peer trials
297 292nd of 2000 higher than 1,707 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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