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NCT00105079 · ClinicalTrials.gov registry record · Phase 3
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
A Phase 3 study of HIV Infections, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 337
- Enrollment target
- 20
- Study locations
NCT00105079: Completed Phase 3 study of HIV Infections, sponsored by Hoffmann-La Roche.
NCT00105079 is a Phase 3 study of HIV Infections that has completed, run by Hoffmann-La Roche. The registered enrollment target is 337 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00105079, a Phase 3 study of HIV Infections, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 337 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Primary Outcome
The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults. Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results \<50 copies/mL is reported.
Conditions Studied
Interventions
- DRUG Ritonavir
- DRUG Emtricitabine/tenofovir disoproxil fumarate
- DRUG Lopinavir/ritonavir
- DRUG saquinavir [Invirase]
Study Locations (20)
Florida
- - Jacksonville
- - Miami
- - Orlando
- - Vero Beach
California
- - Berkeley
- - Los Angeles
Georgia
- - Atlanta
- - Macon
Alabama
- - Hobson City
Arizona
- - Tucson
District of Columbia
- - Washington D.C.
Illinois
- - Chicago
Michigan
- - Ypsilanti
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 337 participants |
| Start Date | 2005-04 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
What the finished NCT00105079 record still lists
NCT00105079 is an interventional study that assigns participants to a tested intervention. The registered 337 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 (24% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 4 interventions - of which Ritonavir is the first listed.
NCT00105079 names 20 study sites across 15 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00105079 about?
NCT00105079 is a clinical study titled "GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection". This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized...
What is the current status of trial NCT00105079?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 337 participants. The study started on 2005-04. Estimated completion is 2008-07.
What conditions does trial NCT00105079 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00105079?
The interventions under investigation include: Ritonavir (DRUG), Emtricitabine/tenofovir disoproxil fumarate (DRUG), Lopinavir/ritonavir (DRUG), saquinavir [Invirase] (DRUG).
Who is sponsoring clinical trial NCT00105079?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00105079 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00105079's enrollment target sits among peer trials
337 104th of 542 higher than 439 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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