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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00105079
The ClinicalTrials.gov registry entry for NCT00105079 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 337 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (24% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Related
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