GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
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ClinicalTrials.gov Identifier: NCT00105079 |
Recruitment Status :
Completed
First Posted : March 7, 2005
Results First Posted : November 2, 2011
Last Update Posted : November 2, 2011
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections | Drug: saquinavir [Invirase] Drug: Lopinavir/ritonavir Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Ritonavir | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 337 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | April 2005 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: saquinavir/ritonavir
saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
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Drug: saquinavir [Invirase]
1000 milligram (mg) Oral (po) twice daily (bid)
Other Name: Invirase Drug: Emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
Other Name: Truvada Drug: Ritonavir 100 mg po bid
Other Name: Norvir |
Active Comparator: lopinavir/ritonavir
lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
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Drug: Lopinavir/ritonavir
Lopinavir/ritonavir 400/100 mg po bid
Other Name: Kaletra Drug: Emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
Other Name: Truvada |
- Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL [ Time Frame: Week 48 ]
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.
- Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL [ Time Frame: Week 48 ]
The secondary objectives of the study were to evaluate the safety, adherence, and tolerability 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 and the number of participants with HIV-1 RNA results <400 copies/mL are reported.
- Change From Baseline in HIV-1 RNA Viral Load [ Time Frame: Baseline to Week 48 ]Descriptive statistics for change from baseline in log10 transformed plasma HIV-1 RNA load (copies/mL) were presented by treatment arm. Logarithmic transformation (base 10) was applied to HIV-1 RNA viral load at baseline and at each study visit. Change from baseline in plasma HIV-1 RNA was derived as follows: Change from baseline = Log10 (HIV-1 RNA at week x) - Log10 (HIV-1 RNA at baseline)
- Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count [ Time Frame: Baseline to Week 48 ]Summary statistics for change from baseline in CD4+ lymphocyte count were presented by treatment arm. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week x) - (CD4+ count at baseline).
- Number of Participants Assessed for Adverse Events (AEs) [ Time Frame: reported up to 28 days after the last dose of study treatment. (Up to 52 weeks) ]Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS.
- Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters [ Time Frame: baseline and all study visits (Up to Week 52) ]Routine clinical testing, including hematology and standard chemistry panel was performed at all study visits. Laboratory tests for a fasting lipid profile and fasting insulin determination were obtained at baseline, weeks 24 and 48, and the 4-week follow-up visit. The number of participants who discontinued treatment due to an abnormal laboratory result at any visit is reported.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105079
United States, Alabama | |
Hobson City, Alabama, United States, 36201 | |
United States, Arizona | |
Tucson, Arizona, United States, 85745 | |
United States, California | |
Berkeley, California, United States, 94705 | |
Los Angeles, California, United States, 90028 | |
United States, District of Columbia | |
Washington, District of Columbia, United States, 20009 | |
United States, Florida | |
Jacksonville, Florida, United States, 32204 | |
Miami, Florida, United States, 33136 | |
Orlando, Florida, United States, 32803 | |
Vero Beach, Florida, United States, 32960 | |
United States, Georgia | |
Atlanta, Georgia, United States, 30309 | |
Macon, Georgia, United States, 31201 | |
United States, Illinois | |
Chicago, Illinois, United States, 60613 | |
United States, Michigan | |
Ypsilanti, Michigan, United States, 48197 | |
United States, Missouri | |
St Louis, Missouri, United States, 63139 | |
United States, New Jersey | |
Newark, New Jersey, United States, 07102 | |
United States, New York | |
New York, New York, United States, 10011 | |
United States, North Carolina | |
Huntersville, North Carolina, United States, 28078 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Houston, Texas, United States, 77004 | |
Canada, Ontario | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Toronto, Ontario, Canada, M4N 3M5 | |
Toronto, Ontario, Canada, M5B 1L6 | |
Toronto, Ontario, Canada, M5G 2C4 | |
Canada, Quebec | |
Montreal, Quebec, Canada, H2L 4P9 | |
Montreal, Quebec, Canada, H2L 5B1 | |
Montreal, Quebec, Canada, H2X 2P4 | |
France | |
Avignon, France, 84902 | |
Lyon, France, 69288 | |
Lyon, France, 69437 | |
Marseille, France, 13009 | |
Marseille, France, 13385 | |
Nantes, France, 44035 | |
Nice, France, 06202 | |
Paris, France, 75010 | |
Paris, France, 75014 | |
Paris, France, 75651 | |
Rouen, France, 73031 | |
Strasbourg, France, 67091 | |
Suresnes, France, 92150 | |
Toulouse, France, 31052 | |
Tourcoing, France, 59208 | |
Puerto Rico | |
Ponce, Puerto Rico, 00717-1563 | |
Thailand | |
Bangkok, Thailand, 10330 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00105079 |
Other Study ID Numbers: |
ML18413 |
First Posted: | March 7, 2005 Key Record Dates |
Results First Posted: | November 2, 2011 |
Last Update Posted: | November 2, 2011 |
Last Verified: | September 2011 |
Infections Ritonavir Lopinavir Saquinavir Tenofovir Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |