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NCT02178800 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 199
- Enrollment target
- 8
- Study locations
NCT02178800: Completed Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02178800 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 199 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (55% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02178800, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 199 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in healthy, HIV-uninfected adults.
Primary Outcome
An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.
Conditions Studied
Interventions
- DRUG GSK1265744 Tablets
- DRUG Injectable GSK1265744
- DRUG Placebo for GSK1265744 Tablets
- DRUG Injectable Placebo for GSK1265744
Study Locations (8)
California
- UCLA CARE Center CRS - Los Angeles
- Bridge HIV CRS - San Francisco
Other
- Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS - Rio de Janeiro
- Malawi CRS - Lilongwe
District of Columbia
- George Washington Univ. CRS - Washington D.C.
North Carolina
- Chapel Hill CRS - Chapel Hill
Gauteng
- Soweto HPTN CRS - Johannesburg
KwaZulu-Natal
- Vulindlela CRS - Durban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2015-02 |
| Est. Completion | 2018-07-13 |
| Phase | Phase 2 |
What the finished NCT02178800 record still lists
NCT02178800 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (55% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which GSK1265744 Tablets is the first listed.
NCT02178800 lists 8 locations in 6 states (California, Other, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT02178800 about?
NCT02178800 is a clinical study titled "Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults". This study will evaluate the safety, tolerability, and pharmacokinetics (which is how the body interacts with drugs) of an investigational, injectable HIV medicine (GSK1265744) in healthy, HIV-uninfected adults.
What is the current status of trial NCT02178800?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 199 participants. The study started on 2015-02. Estimated completion is 2018-07-13.
What conditions does trial NCT02178800 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT02178800?
The interventions under investigation include: GSK1265744 Tablets (DRUG), Injectable GSK1265744 (DRUG), Placebo for GSK1265744 Tablets (DRUG), Injectable Placebo for GSK1265744 (DRUG).
Who is sponsoring clinical trial NCT02178800?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02178800 being conducted?
This trial has 8 study locations across California, District of Columbia, North Carolina, Gauteng, KwaZulu-Natal. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
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 NCT02178800's enrollment target sits among peer trials
199 182nd of 542 higher than 361 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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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