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

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: saquinavir [Invirase] Drug: Lopinavir/ritonavir Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Ritonavir	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Formic acid Saquinavir Emtricitabine Tenofovir Saquinavir mesylate Ritonavir Lopinavir Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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.


Enrollment:	337
Study Start Date:	April 2005
Study Completion Date:	July 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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.	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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105079

Show 44 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00105079 History of Changes
Other Study ID Numbers:	ML18413
Study First Received:	March 4, 2005
Results First Received:	March 29, 2011
Last Updated:	September 23, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Infection HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Saquinavir Tenofovir	Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV 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

ClinicalTrials.gov processed this record on September 29, 2016