GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
Public ClinicalTrials.gov record NCT00105079. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients (GEMINI Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00105079
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 337 participants
Conditions and interventions
Conditions
Interventions
- saquinavir [Invirase] Drug
- Lopinavir/ritonavir Drug
- Emtricitabine/tenofovir disoproxil fumarate Drug
- Ritonavir Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2005 (Type not available)
- Primary completion
- Aug 2007 (Actual)
- Completion
- Jul 2008 (Actual)
- Last update posted
- Nov 2, 2011
2005 – 2008
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Hobson City | Alabama | 36201 | — |
| Not listed | Tucson | Arizona | 85745 | — |
| Not listed | Berkeley | California | 94705 | — |
| Not listed | Los Angeles | California | 90028 | — |
| Not listed | Washington D.C. | District of Columbia | 20009 | — |
| Not listed | Jacksonville | Florida | 32204 | — |
| Not listed | Miami | Florida | 33136 | — |
| Not listed | Orlando | Florida | 32803 | — |
| Not listed | Vero Beach | Florida | 32960 | — |
| Not listed | Atlanta | Georgia | 30309 | — |
| Not listed | Macon | Georgia | 31201 | — |
| Not listed | Chicago | Illinois | 60613 | — |
| Not listed | Ypsilanti | Michigan | 48197 | — |
| Not listed | St Louis | Missouri | 63139 | — |
| Not listed | Newark | New Jersey | 07102 | — |
| Not listed | New York | New York | 10011 | — |
| Not listed | Huntersville | North Carolina | 28078 | — |
| Not listed | Philadelphia | Pennsylvania | 19107 | — |
| Not listed | Houston | Texas | 77004 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00105079, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2011 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00105079 live on ClinicalTrials.gov.