Trial · NCT00105079

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

NCT00105079, Phase 3, Completed, Hoffmann-La Roche; results first posted 2011-11-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection. Trials, record NCT00105079. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00105079

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
NCT number: NCT00105079
Status: Completed
Phases: Phase 3
Enrollment: 337 participants, actual
Lead sponsor: Hoffmann-La Roche
Conditions: HIV Infections
Interventions: saquinavir [Invirase], Lopinavir/ritonavir, Emtricitabine/tenofovir disoproxil fumarate, Ritonavir
First posted: 2005-03-07
Last updated: 2011-11-02
Results first posted: 2011-11-02

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL	Week 48	The primary objective of this study was to evaluate the efficacy 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 is reported.
Secondary	Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL	Week 48	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.
Secondary	Change From Baseline in HIV-1 RNA Viral Load	Baseline to Week 48	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)
Secondary	Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count	Baseline to Week 48	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).
Secondary	Number of Participants Assessed for Adverse Events (AEs)	reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)	Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS.
Secondary	Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters	baseline and all study visits (Up to Week 52)	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL	Week 48	intent-to-treat (ITT) Population	participants	NUMBER
SECONDARY	Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL	Week 48	Intent-to-Treat Population	participants	NUMBER
SECONDARY	Change From Baseline in HIV-1 RNA Viral Load	Baseline to Week 48	ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.	copies/mL	MEAN
SECONDARY	Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count	Baseline to Week 48	ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.	cells/mm^3	MEDIAN
SECONDARY	Number of Participants Assessed for Adverse Events (AEs)	reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)	Safety population included all randomized patients who received at least one dose of study medication	participants	NUMBER
SECONDARY	Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters	baseline and all study visits (Up to Week 52)	Safety population included all randomized patients who received at least one dose of study medication.	participants	NUMBER

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL	Saquinavir/Ritonavir	Pts. with HIV-1 RNA Viral Load <50 copies/mL - YES	108		participants
Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL	Lopinavir/Ritonavir	Pts. with HIV-1 RNA Viral Load <50 copies/mL - YES	108		participants
Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL	Saquinavir/Ritonavir	Pts. with HIV-1 RNA Viral Load <50 copies/mL - NO	59		participants
Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL	Lopinavir/Ritonavir	Pts. with HIV-1 RNA Viral Load <50 copies/mL - NO	62		participants
Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL	Saquinavir/Ritonavir	Patients with <50 Copies/mL	108	57.4 to 71.9	participants
Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL	Lopinavir/Ritonavir	Patients with <50 Copies/mL	108	56.3 to 70.8	participants
Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL	Saquinavir/Ritonavir	Patients with <400 Copies/mL	121	65.7 to 79.2	participants
Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL	Lopinavir/Ritonavir	Patients with <400 Copies/mL	127	68.2 to 81.2	participants
Change From Baseline in HIV-1 RNA Viral Load	Saquinavir/Ritonavir	Baseline	5.20	95% Confidence Interval 5.1 to 5.3	copies/mL
Change From Baseline in HIV-1 RNA Viral Load	Lopinavir/Ritonavir	Baseline	5.17	95% Confidence Interval 5.1 to 5.3	copies/mL

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Saquinavir/Ritonavir	167
Overall Study	STARTED	Lopinavir/Ritonavir	170
Overall Study	Safety Population	Saquinavir/Ritonavir	163
Overall Study	Safety Population	Lopinavir/Ritonavir	168
Overall Study	COMPLETED	Saquinavir/Ritonavir	128
Overall Study	COMPLETED	Lopinavir/Ritonavir	135
Overall Study	NOT COMPLETED	Saquinavir/Ritonavir	39
Overall Study	NOT COMPLETED	Lopinavir/Ritonavir	35

Source ClinicalTrials.gov

Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Upper respiratory tract infection	Infections and infestations	Saquinavir/Ritonavir	11	163
other	Upper respiratory tract infection	Infections and infestations	Lopinavir/Ritonavir	23	168
other	Bronchitis	Infections and infestations	Saquinavir/Ritonavir	10	163
other	Bronchitis	Infections and infestations	Lopinavir/Ritonavir	5	168
other	Diarrhoea	Gastrointestinal disorders	Saquinavir/Ritonavir	46	163
other	Diarrhoea	Gastrointestinal disorders	Lopinavir/Ritonavir	77	168
other	Nausea	Gastrointestinal disorders	Saquinavir/Ritonavir	40	163
other	Nausea	Gastrointestinal disorders	Lopinavir/Ritonavir	55	168
other	Vomiting	Gastrointestinal disorders	Saquinavir/Ritonavir	21	163
other	Vomiting	Gastrointestinal disorders	Lopinavir/Ritonavir	28	168

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Saquinavir/Ritonavir
Total, all-cause mortality	Lopinavir/Ritonavir
Total, other adverse events	Saquinavir/Ritonavir	76	163
Total, other adverse events	Lopinavir/Ritonavir	92	168
Total, serious adverse events	Saquinavir/Ritonavir	24	163
Total, serious adverse events	Lopinavir/Ritonavir	19	168

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Saquinavir/Ritonavir vs Lopinavir/Ritonavir: Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters	Trial comparisons
Saquinavir/Ritonavir vs Lopinavir/Ritonavir: Number of Participants Assessed for Adverse Events (AEs)	Trial comparisons
Saquinavir/Ritonavir vs Lopinavir/Ritonavir: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00105079

GET https://conductscience.org/api/trials/v1/NCT00105079/results?page=2

API reference For AI assistants