Conditions: HIV Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 337
Healthy volunteers: no

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:

Arms:
arm 1: saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. arm 2: lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.

Interventions: intervention 1: saquinavir [Invirase] intervention 2: Lopinavir/ritonavir intervention 3: Emtricitabine/tenofovir disoproxil fumarate intervention 4: Ritonavir
Intervention descriptions: intervention 1: 1000 milligram (mg) Oral (po) twice daily (bid) intervention 2: Lopinavir/ritonavir 400/100 mg po bid intervention 3: Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd intervention 4: 100 mg po bid

Protocol document: