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NCT00440947 · ClinicalTrials.gov registry record · Phase 3
Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection
A Phase 3 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 515
- Enrollment target
NCT00440947: Completed Phase 3 study, sponsored by ViiV Healthcare.
NCT00440947 is a Phase 3 study that has completed, run by ViiV Healthcare. The registered enrollment target is 515 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00440947, a Phase 3 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 515 participants
- Enrollment target
Study Summary
This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B\*5701 negative subjects. All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.
Primary Outcome
The percentage of PAR with HIV-1 RNA virus \<50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 c/ml and \>=100,000 c/ml). 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
Interventions
- DRUG Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)
- DRUG Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2007-03 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT00440947 record still lists
NCT00440947 is an interventional study that assigns participants to a tested intervention. The registered 515 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) is the first listed.
NCT00440947 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00440947 about?
NCT00440947 is a clinical study titled "Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection". This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simpl...
What is the current status of trial NCT00440947?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 515 participants. The study started on 2007-03. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00440947?
The interventions under investigation include: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r) (DRUG), Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) (DRUG).
Who is sponsoring clinical trial NCT00440947?
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 NCT00440947's enrollment target sits among peer trials
515 724th of 2000 higher than 1,277 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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