GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00105079
First received: March 4, 2005
Last updated: September 23, 2011
Last verified: September 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: March 29, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
HIV Infections |
| Interventions: |
Drug: saquinavir [Invirase] Drug: Lopinavir/ritonavir Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Ritonavir |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| This study was conducted between 28 April 2005 and 24 August 2007 at 38 study centers in the United States, Canada, France and Thailand. Patients were randomized to receive saquinavir/ritonavir 1000/100 mg PO BID plus emtricitabine/tenofovir 200/300 mg PO QD or lopinavir/ritonavir 400/100 mg PO BID plus emtricitabine/tenofovir 200/300 mg PO QD . |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 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. |
| Lopinavir/Ritonavir | lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. |
Participant Flow: Overall Study
| Saquinavir/Ritonavir | Lopinavir/Ritonavir | |
|---|---|---|
| STARTED | 167 | 170 |
| Safety Population | 163 | 168 |
| COMPLETED | 128 | 135 |
| NOT COMPLETED | 39 | 35 |
| Adverse Event | 5 | 12 |
| Death | 3 | 1 |
| Lost to Follow-up | 12 | 12 |
| Lack of Efficacy | 9 | 3 |
| Refused treatment | 6 | 4 |
| Violation of selection criteria at entry | 0 | 2 |
| Protocol Violation | 1 | 0 |
| not specified | 3 | 1 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 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. |
| Lopinavir/Ritonavir | lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. |
| Total | Total of all reporting groups |
Baseline Measures
| Saquinavir/Ritonavir | Lopinavir/Ritonavir | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
167 | 170 | 337 |
|
Age
[units: years] Mean ± Standard Deviation |
38.3 ± 9.31 | 37.9 ± 9.60 | 38.1 ± 9.45 |
|
Gender
[units: participants] |
|||
| Female | 31 | 39 | 70 |
| Male | 136 | 131 | 267 |
Outcome Measures
| 1. Primary: | Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL [ Time Frame: Week 48 ] |
| 2. Secondary: | Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL [ Time Frame: Week 48 ] |
| 3. Secondary: | Change From Baseline in HIV-1 RNA Viral Load [ Time Frame: Baseline to Week 48 ] |
| 4. Secondary: | Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count [ Time Frame: Baseline to Week 48 ] |
| 5. Secondary: | 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) ] |
| 6. Secondary: | Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters [ Time Frame: baseline and all study visits (Up to Week 52) ] |