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NCT00950859 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir
A Phase 2 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 20
- Study locations
NCT00950859: Completed Phase 2 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
NCT00950859 is a Phase 2 study of Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 51 participants, below the 145-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00950859, a Phase 2 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 20
- Study locations
Study Summary
Integrase is an enzyme produced by HIV so that the virus can multiply in the human body. GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from working properly and therefore prevents the virus from multiplying. GSK1349572 has shown to be effective against viruses in a short-term monotherapy study in adults with no previous exposure to integrase inhibitors. The purpose of this study is to determine whether GSK1349572 is effective in the treatment of HIV-infected patients who no longer respond to treatment with the approved integrase inhibitor raltegravir and carry viruses with resistance to this drug. The safety and efficacy of GSK1349572 50mg once daily in combination with the background HIV drugs previously administered (unless discontinuation of a particular drug is required) will be assessed over 10 days (functional monotherapy phase), followed by the evaluation of the safety and efficacy of GSK1349572 given with a new optimised background regimen from Day 11 through at least Week 24.
Primary Outcome
The number of participants who acheived Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11 was assessed. The last observation was carried forward if a participant had missed the Day 11 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 11. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 11.
Conditions Studied
Interventions
- DRUG GSK1349572 (Cohort I)
- DRUG GSK1349572 (Cohort II)
Study Locations (20)
Other
- GSK Investigational Site - Bordeaux
- GSK Investigational Site - Le Kremlin-Bicêtre
- GSK Investigational Site - Lyon
- GSK Investigational Site - Marseille
- GSK Investigational Site - Montpellier
- GSK Investigational Site - Nice
Florida
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Fort Lauderdale
- GSK Investigational Site - Orlando
California
- GSK Investigational Site - Long Beach
- GSK Investigational Site - San Francisco
North Carolina
- GSK Investigational Site - Chapel Hill
- GSK Investigational Site - Charlotte
Arizona
- GSK Investigational Site - Phoenix
Colorado
- GSK Investigational Site - Denver
District of Columbia
- GSK Investigational Site - Washington D.C.
New Mexico
- GSK Investigational Site - Santa Fe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2009-08 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
What the finished NCT00950859 record still lists
NCT00950859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 145-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 2 interventions - of which GSK1349572 (Cohort I) is the first listed.
NCT00950859 names 20 study sites across 11 states, led by Other, Florida, California.
Frequently Asked Questions
What is clinical trial NCT00950859 about?
NCT00950859 is a clinical study titled "A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir". Integrase is an enzyme produced by HIV so that the virus can multiply in the human body. GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from working properly and therefore prevents the virus from multiplying. GSK1349572 has shown to be effective against viruses i...
What is the current status of trial NCT00950859?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2009-08. Estimated completion is 2015-01.
What conditions does trial NCT00950859 study?
This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT00950859?
The interventions under investigation include: GSK1349572 (Cohort I) (DRUG), GSK1349572 (Cohort II) (DRUG).
Who is sponsoring clinical trial NCT00950859?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00950859 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00950859's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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