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NCT02165202 · ClinicalTrials.gov registry record · Phase 2
Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis
A Phase 2 study of Human Immunodeficiency Virus (HIV), sponsored by PATH.
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
- 4
- Study locations
NCT02165202: Completed Phase 2 study of Human Immunodeficiency Virus (HIV), sponsored by PATH.
NCT02165202 is a Phase 2 study of Human Immunodeficiency Virus (HIV) that has completed, run by PATH. The registered enrollment target is 136 participants, below the 501-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (73% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02165202, a Phase 2 study of Human Immunodeficiency Virus (HIV), has completed, sponsored by PATH.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active, HIV- uninfected women.
Primary Outcome
Number of participants experiencing any Grade 2 or higher clinical and laboratory AEs to evaluate the safety of the injectable product, TMC278 LA (1200 mg dose administered at Weeks 4, 12, 20, 28, 36 and 44), through 48 weeks after initial injection (at Week 52) in women in SSA and the US.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rilpivirine
Study Locations (4)
New Jersey
- New Jersey Medical School Clinical Research Center - Newark
New York
- Bronx Prevention Center - The Bronx
Other
- Emavundleni Clinical Research Site - Cape Town
Harare
- Spilhaus Clinical Research Site - Belgravia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2014-10 |
| Est. Completion | 2017-03-09 |
| Phase | Phase 2 |
What the finished NCT02165202 record still lists
NCT02165202 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 501-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Human Immunodeficiency Virus (HIV) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02165202 reports a single indexed study location in New Jersey, New York, Other.
Frequently Asked Questions
What is clinical trial NCT02165202 about?
NCT02165202 is a clinical study titled "Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis". This is a multi-site, double-blinded, two-arm, two:one, randomized, trial comparing the safety of an intramuscular (IM) injection of TMC278 LA to a placebo given once every eight weeks over a 40 week period among sexually active, HIV- uninfected women.
What is the current status of trial NCT02165202?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2014-10. Estimated completion is 2017-03-09.
What conditions does trial NCT02165202 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV).
What interventions are being tested in trial NCT02165202?
The interventions under investigation include: Placebo (DRUG), Rilpivirine (DRUG).
Who is sponsoring clinical trial NCT02165202?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02165202 being conducted?
This trial has 4 study locations across New Jersey, New York, Harare. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Human Immunodeficiency Virus (HIV)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02165202's enrollment target sits among peer trials
136 9th of 18 higher than 10 of 18 other Human Immunodeficiency Virus (HIV) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Immunodeficiency Virus (HIV) 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.
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