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

• 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.

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.

• Drug: saquinavir [Invirase]
  1000 milligram (mg) Oral (po) twice daily (bid)
  Other Name: Invirase
• 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
• Drug: Ritonavir
  100 mg po bid
  Other Name: Norvir

• 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.
  Interventions:

  • Drug: saquinavir [Invirase]
  • Drug: Emtricitabine/tenofovir disoproxil fumarate
  • Drug: Ritonavir
• Active Comparator: lopinavir/ritonavir
  lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
  Interventions:

  • Drug: Lopinavir/ritonavir
  • Drug: Emtricitabine/tenofovir disoproxil fumarate

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.