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NCT01384734 · ClinicalTrials.gov registry record · Phase 2
HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections
A Phase 2 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 254
- Enrollment target
NCT01384734: Completed Phase 2 study, sponsored by ViiV Healthcare.
NCT01384734 is a Phase 2 study that has completed, run by ViiV Healthcare. The registered enrollment target is 254 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01384734, a Phase 2 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 254 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with RAL + TDF for treatment-experienced HIV-1 infected subjects. PHENOSENSE® is a registered trademark of Monogram Biosciences.
Primary Outcome
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-tr
Interventions
- DRUG BMS-663068 400 mg
- DRUG BMS-663068 800 mg
- DRUG BMS-663068 600 mg
- DRUG BMS-663068 1200 mg
- DRUG Raltegravir 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2011-07-26 |
| Est. Completion | 2017-05-12 |
| Phase | Phase 2 |
What the finished NCT01384734 record still lists
NCT01384734 is an interventional study that assigns participants to a tested intervention. The registered 254 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 (91% higher).
The record links to 0 conditions, and to 5 interventions - of which BMS-663068 400 mg is the first listed.
NCT01384734 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01384734 about?
NCT01384734 is a clinical study titled "HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections". The purpose of this study is to assess the safety, efficacy, tolerability and pharmacokinetics of four doses of BMS-663068 with Raltegravir (RAL) + Tenofovir Disoproxil Fumarate (TDF). At least 1 dose of BMS-663068 can be identified which is safe, well tolerated, and efficacious when combined with R...
What is the current status of trial NCT01384734?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 254 participants. The study started on 2011-07-26. Estimated completion is 2017-05-12.
What interventions are being tested in trial NCT01384734?
The interventions under investigation include: BMS-663068 400 mg (DRUG), BMS-663068 800 mg (DRUG), BMS-663068 600 mg (DRUG), BMS-663068 1200 mg (DRUG), Raltegravir 400 mg (DRUG).
Who is sponsoring clinical trial NCT01384734?
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 NCT01384734's enrollment target sits among peer trials
254 219th of 2000 higher than 1,781 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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