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

This study has been completed.

Sponsor:

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

History of Changes

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

Hide 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

Hide 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

Show All 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 ]

Show Outcome Measure 1

2. Secondary:

Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL [ Time Frame: Week 48 ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in HIV-1 RNA Viral Load [ Time Frame: Baseline to Week 48 ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count [ Time Frame: Baseline to Week 48 ]

Hide Outcome Measure 4

Measure Type	Secondary
Measure Title	Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count
Measure Description	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).
Time Frame	Baseline to Week 48
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

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.

Measured Values

	Saquinavir/Ritonavir	Lopinavir/Ritonavir
Number of Participants Analyzed [units: participants]	167	170
Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count [units: cells/mm^3] Median ( 95% Confidence Interval )
Baseline (n=166,169)	141.5 ( 108.0 to 168.0 )	142.0 ( 116.0 to 187.0 )
Week 48 (n=122,131)	319.0 ( 277.0 to 370.0 )	348.0 ( 317.0 to 401.0 )
Change from Baseline to Week 48 (n=121,130)	178.0 ( 159.0 to 213.0 )	204.0 ( 182.0 to 222.0 )

No statistical analysis provided for Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count

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) ]

Show Outcome Measure 5

6. Secondary:

Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters [ Time Frame: baseline and all study visits (Up to Week 52) ]

Show Outcome Measure 6

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00105079 History of Changes
Other Study ID Numbers:	ML18413
Study First Received:	March 4, 2005
Results First Received:	March 29, 2011
Last Updated:	September 23, 2011
Health Authority:	United States: Food and Drug Administration

To Top