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NCT01003990 · ClinicalTrials.gov registry record · Phase 3
Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 710
- Enrollment target
NCT01003990: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01003990 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 710 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01003990, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 710 participants
- Enrollment target
Study Summary
The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.
Primary Outcome
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grad
Interventions
- DRUG Atazanavir
- DRUG Tenofovir/Emtricitabine
- DRUG Lopinavir/ritonavir
- DRUG Atazanavir/Ritonavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 710 participants |
| Start Date | 2002-10 |
| Est. Completion | 2016-02 |
| Phase | Phase 3 |
What the finished NCT01003990 record still lists
NCT01003990 is an interventional study that assigns participants to a tested intervention. The registered 710 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Atazanavir is the first listed.
NCT01003990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01003990 about?
NCT01003990 is a clinical study titled "Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access". The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.
What is the current status of trial NCT01003990?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 710 participants. The study started on 2002-10. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01003990?
The interventions under investigation include: Atazanavir (DRUG), Tenofovir/Emtricitabine (DRUG), Lopinavir/ritonavir (DRUG), Atazanavir/Ritonavir (DRUG).
Who is sponsoring clinical trial NCT01003990?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01003990's enrollment target sits among peer trials
710 502nd of 2000 higher than 1,496 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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