Clinical trial NCT00105079: GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-03-07
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic HIV-1 infection;
* treatment-naive;
* HIV-1 RNA viral load \>=10,000copies/mL;
* women of childbearing potential must have a negative pregnancy test, and must use reliable contraception for the duration of the study and for 90 days after the last dose of study medication.

Exclusion Criteria:

* females who are pregnant or breastfeeding;
* active hepatitis B infection;
* previous treatment with antiretroviral medication;
* patients who have received an investigational drug within the last 4 weeks.

Primary outcomes:
measure: Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
timeFrame: Week 48
Secondary outcomes:
measure: Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL
timeFrame: Week 48
measure: Change From Baseline in HIV-1 RNA Viral Load
timeFrame: Baseline to Week 48
measure: Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count
timeFrame: Baseline to Week 48
measure: Number of Participants Assessed for Adverse Events (AEs)
timeFrame: reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)
measure: Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters
timeFrame: baseline and all study visits (Up to Week 52)
Other outcomes:
Locations:
city: Hobson City
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Berkeley
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Ypsilanti
country: United States
state: Michigan
city: St Louis
country: United States
state: Missouri
city: Newark
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Huntersville
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Avignon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Nantes
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Rouen
country: France
city: Strasbourg
country: France
city: Suresnes
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
city: Ponce
country: Puerto Rico
city: Bangkok
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: