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

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Drug: saquinavir [Invirase]; Drug: Lopinavir/ritonavir; Drug: Emtricitabine/tenofovir disoproxil fumarate; Drug: Ritonavir

• Registration Number: NCT00105079
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-03-04
• Study First Submitted QC: 2005-03-04
• Study First Posted: 2005-03-07
• Study Start: 2005-04
• Primary Completion: 2007-08
• Study Completion: 2008-07
• Results First Submitted: 2011-03-29
• Status Verified: 2011-09
• Results First Submitted QC: 2011-09-23
• Last Update Submitted: 2011-09-23
• Results First Posted: 2011-11-02
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lopinavir/ritonavir	Emtricitabine/tenofovir disoproxil fumarate	lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
saquinavir/ritonavir	saquinavir [Invirase]	saquinavir 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	Lopinavir/ritonavir	lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
saquinavir/ritonavir	Emtricitabine/tenofovir disoproxil fumarate	saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
saquinavir/ritonavir	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in HIV-1 RNA Viral Load	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)
Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters	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.
Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL	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 Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count	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)	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.