GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
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)
1 other identifier
interventional
337
5 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
Started Apr 2005
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2005
CompletedFirst Posted
Study publicly available on registry
March 7, 2005
CompletedStudy Start
First participant enrolled
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
November 2, 2011
CompletedNovember 2, 2011
September 1, 2011
2.3 years
March 4, 2005
March 29, 2011
September 23, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
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.
Week 48
Secondary Outcomes (5)
Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL
Week 48
Change From Baseline in HIV-1 RNA Viral Load
Baseline to Week 48
Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count
Baseline to Week 48
Number of Participants Assessed for Adverse Events (AEs)
reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)
Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters
baseline and all study visits (Up to Week 52)
Study Arms (2)
saquinavir/ritonavir
EXPERIMENTALsaquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
lopinavir/ritonavir
ACTIVE COMPARATORlopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
Interventions
1000 milligram (mg) Oral (po) twice daily (bid)
Lopinavir/ritonavir 400/100 mg po bid
Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Hobson City, Alabama, 36201, United States
Unknown Facility
Tucson, Arizona, 85745, United States
Unknown Facility
Berkeley, California, 94705, United States
Unknown Facility
Los Angeles, California, 90028, United States
Unknown Facility
Washington D.C., District of Columbia, 20009, United States
Unknown Facility
Jacksonville, Florida, 32204, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Vero Beach, Florida, 32960, United States
Unknown Facility
Atlanta, Georgia, 30309, United States
Unknown Facility
Macon, Georgia, 31201, United States
Unknown Facility
Chicago, Illinois, 60613, United States
Unknown Facility
Ypsilanti, Michigan, 48197, United States
Unknown Facility
St Louis, Missouri, 63139, United States
Unknown Facility
Newark, New Jersey, 07102, United States
Unknown Facility
New York, New York, 10011, United States
Unknown Facility
Huntersville, North Carolina, 28078, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Houston, Texas, 77004, United States
Unknown Facility
Hamilton, Ontario, L8N 3Z5, Canada
Unknown Facility
Ottawa, Ontario, K1H 8L6, Canada
Unknown Facility
Toronto, Ontario, M4N 3M5, Canada
Unknown Facility
Toronto, Ontario, M5B 1L6, Canada
Unknown Facility
Toronto, Ontario, M5G 2C4, Canada
Unknown Facility
Montreal, Quebec, H2L 4P9, Canada
Unknown Facility
Montreal, Quebec, H2L 5B1, Canada
Unknown Facility
Montreal, Quebec, H2X 2P4, Canada
Unknown Facility
Avignon, 84902, France
Unknown Facility
Lyon, 69288, France
Unknown Facility
Lyon, 69437, France
Unknown Facility
Marseille, 13009, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Nantes, 44035, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Paris, 75010, France
Unknown Facility
Paris, 75014, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Rouen, 73031, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Suresnes, 92150, France
Unknown Facility
Toulouse, 31052, France
Unknown Facility
Tourcoing, 59208, France
Unknown Facility
Ponce, 00717-1563, Puerto Rico
Unknown Facility
Bangkok, 10330, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2005
First Posted
March 7, 2005
Study Start
April 1, 2005
Primary Completion
August 1, 2007
Study Completion
July 1, 2008
Last Updated
November 2, 2011
Results First Posted
November 2, 2011
Record last verified: 2011-09