Phase 3
Completed N=337
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
Source: ClinicalTrials.gov NCT00105079 ↗Enrolled (actual)
337
Serious AEs
13.0%
Results posted
Nov 2011
Primary outcomePrimary: Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL — 108; 108; 59; 62 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL |
108; 108; 59; 62 | — |
| SECONDARY Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL |
108; 108; 121; 127 | — |
| SECONDARY Change From Baseline in HIV-1 RNA Viral Load |
5.20; 5.17; 1.80; 1.83; -3.39; -3.36 | — |
| SECONDARY Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count |
141.5; 142.0; 319.0; 348.0; 178.0; 204.0 | — |
| SECONDARY Number of Participants Assessed for Adverse Events (AEs) |
163; 168 | — |
| SECONDARY Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters |
0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00105079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.