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GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection

NCT00105079 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2011-11-02

Study results available
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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

  • HIV Infections

Interventions

DRUG

saquinavir [Invirase]

1000 milligram (mg) Oral (po) twice daily (bid)

DRUG

Lopinavir/ritonavir

Lopinavir/ritonavir 400/100 mg po bid

DRUG

Emtricitabine/tenofovir disoproxil fumarate

Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd

DRUG

Ritonavir

100 mg po bid

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2007-08-31
Completion
2008-07-31

Countries

  • United States
  • Canada
  • France
  • Puerto Rico
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00105079 on ClinicalTrials.gov