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

Roche

Status and phase

Completed

Phase 3

Conditions

HIV Infections

Treatments

Drug: Emtricitabine/tenofovir disoproxil fumarate

Drug: saquinavir [Invirase]

Drug: Lopinavir/ritonavir

Drug: Ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00105079

ML18413

Details and patient eligibility

About

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.

Enrollment

337 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

337 participants in 2 patient groups

saquinavir/ritonavir

Experimental group

Description:

saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.

Treatment:

Drug: Ritonavir

Drug: Emtricitabine/tenofovir disoproxil fumarate

Drug: saquinavir [Invirase]

lopinavir/ritonavir

Active Comparator group

Description:

lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.

Treatment:

Drug: Lopinavir/ritonavir

Drug: Emtricitabine/tenofovir disoproxil fumarate