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NCT01218113 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons
A Phase 2 study of AIDS, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 191
- Enrollment target
- 20
- Study locations
NCT01218113: Completed Phase 2 study of AIDS, sponsored by GlaxoSmithKline.
NCT01218113 is a Phase 2 study of AIDS that has completed, run by GlaxoSmithKline. The registered enrollment target is 191 participants, below the 1,567-participant average among 13 other AIDS trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01218113, a Phase 2 study of AIDS, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 191 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.
Primary Outcome
Changes from baseline in HIV-1 viral load (ratio of each value over baseline value) were obtained using crude values and expressed in RNA copies/milliliter \[copies/mL\]. Baseline of HIV-1 viral load was defined as geometric mean of values measured in blood samples taken at Screening and at Week 0. The HIV type 1, represents the more aggressive virus form, largely responsible for the AIDS pandemic.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL GSK Biologicals HIV Vaccine 732462
Study Locations (20)
Florida
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Jacksonville
- GSK Investigational Site - Orlando
New Jersey
- GSK Investigational Site - Camden
- GSK Investigational Site - Newark
- GSK Investigational Site - Somers Point
Other
- GSK Investigational Site - Bobigny
- GSK Investigational Site - Créteil
- GSK Investigational Site - Nantes
California
- GSK Investigational Site - Bakersfield
- GSK Investigational Site - Long Beach
Pennsylvania
- GSK Investigational Site - Philadelphia
- GSK Investigational Site - Philadelphia
District of Columbia
- GSK Investigational Site - Washington D.C.
Nebraska
- GSK Investigational Site - Omaha
Ohio
- GSK Investigational Site - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2010-11-08 |
| Est. Completion | 2012-11-05 |
| Phase | Phase 2 |
What the finished NCT01218113 record still lists
NCT01218113 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, below the 1,567-participant average among 13 other AIDS trials with a reported enrollment target (88% lower).
The record links to 1 condition, with AIDS appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01218113 names 20 study sites across 12 states, led by Florida, New Jersey, Other.
Frequently Asked Questions
What is clinical trial NCT01218113 about?
NCT01218113 is a clinical study titled "Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons". This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (AR...
What is the current status of trial NCT01218113?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 191 participants. The study started on 2010-11-08. Estimated completion is 2012-11-05.
What conditions does trial NCT01218113 study?
This clinical trial studies the following conditions: AIDS.
What interventions are being tested in trial NCT01218113?
The interventions under investigation include: Placebo (DRUG), GSK Biologicals HIV Vaccine 732462 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01218113?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01218113 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01218113's enrollment target sits among peer trials
191 4th of 13 higher than 10 of 13 other AIDS trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other AIDS 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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