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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105079
• Other study ID #: ML18413
• Status: Completed
• Phase: Phase 3
• First received: March 4, 2005
• Last updated: September 23, 2011
• Start date: April 2005
• Est. completion date: July 2008

Study information

• Verified date: September 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: July 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• saquinavir [Invirase]
1000 milligram (mg) Oral (po) twice daily (bid)
• Lopinavir/ritonavir
Lopinavir/ritonavir 400/100 mg po bid
• Emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
• Ritonavir
100 mg po bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  France,  Puerto Rico,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL	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.	Week 48	No
Secondary	Change From Baseline in HIV-1 RNA Viral Load	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)	Baseline to Week 48	No
Secondary	Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count	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).	Baseline to Week 48	No
Secondary	Number of Participants Assessed for Adverse Events (AEs)	Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS.	reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)	No
Secondary	Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters	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.	baseline and all study visits (Up to Week 52)	No