HIV InfectionsPhase 3NCT00105079

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

A Phase 3 study testing saquinavir [Invirase], Lopinavir/ritonavir and Emtricitabine/tenofovir disoproxil fumarate in people with HIV Infections, run by Hoffmann-La Roche at 44 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: saquinavir [Invirase], Lopinavir/ritonavir and Emtricitabine/tenofovir disoproxil fumarate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 337 participants
Where: 44 sitesin 5 countries
Study dates: Apr 2005to Jul 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

44 sites in 5 countries.

Country

City, postcode or hospital

44 sites in 5 countries

United States19 sites

Study site
Atlanta, Georgia, 30309
Study site
Berkeley, California, 94705
Study site
Chicago, Illinois, 60613
Study site
Hobson City, Alabama, 36201
Study site
Houston, Texas, 77004
Study site
Huntersville, North Carolina, 28078
Study site
Jacksonville, Florida, 32204
Study site
Los Angeles, California, 90028
Study site
Macon, Georgia, 31201
Study site
Miami, Florida, 33136
Study site
New York, New York, 10011
Study site
Newark, New Jersey, 07102
Study site
Orlando, Florida, 32803
Study site
Philadelphia, Pennsylvania, 19107
Study site
St Louis, Missouri, 63139
Study site
Tucson, Arizona, 85745
Study site
Vero Beach, Florida, 32960
Study site
Washington D.C., District of Columbia, 20009
Study site
Ypsilanti, Michigan, 48197

Other trials in United States

France15 sites

Study site
Avignon, 84902
Study site
Lyon, 69288
Study site
Lyon, 69437
Study site
Marseille, 13009
Study site
Marseille, 13385
Study site
Nantes, 44035
Study site
Nice, 06202
Study site
Paris, 75010
Study site
Paris, 75014
Study site
Paris, 75651
Study site
Rouen, 73031
Study site
Strasbourg, 67091
Study site
Suresnes, 92150
Study site
Toulouse, 31052
Study site
Tourcoing, 59208

Other trials in France

Canada8 sites

Study site
Hamilton, Ontario, L8N 3Z5
Study site
Montreal, Quebec, H2L 4P9
Study site
Montreal, Quebec, H2L 5B1
Study site
Montreal, Quebec, H2X 2P4
Study site
Ottawa, Ontario, K1H 8L6
Study site
Toronto, Ontario, M4N 3M5
Study site
Toronto, Ontario, M5B 1L6
Study site
Toronto, Ontario, M5G 2C4

Other trials in Canada

Puerto Rico1 site

Study site
Ponce, 00717-1563

Other trials in Puerto Rico

Thailand1 site

Study site
Bangkok, 10330

Other trials in Thailand

About this study

Official title: A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients (GEMINI Study)

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.

Conditions: HIV Infections
Being tested: saquinavir [Invirase], Lopinavir/ritonavir, Emtricitabine/tenofovir disoproxil fumarate, Ritonavir
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

saquinavir [Invirase]Drug
Also called Invirase
1000 milligram (mg) Oral (po) twice daily (bid)
Lopinavir/ritonavirDrug
Also called Kaletra
Lopinavir/ritonavir 400/100 mg po bid
Emtricitabine/tenofovir disoproxil fumarateDrug
Also called Truvada
Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd
RitonavirDrug
Also called Norvir
100 mg po bid

Study groups in NCT00105079
Study group	Role	What they receive
saquinavir/ritonavir	Experimental	saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. Receives: Drug: saquinavir [Invirase]; Drug: Emtricitabine/tenofovir disoproxil fumarate; Drug: Ritonavir
lopinavir/ritonavir	Active comparator	lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks. Receives: Drug: Lopinavir/ritonavir; Drug: Emtricitabine/tenofovir disoproxil fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
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.
Measured: Week 48

Secondary outcomes (5)

Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL
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.
Measured: Week 48
Change From Baseline in HIV-1 RNA Viral Load
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)
Measured: Baseline to Week 48
Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count
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).
Measured: Baseline to Week 48
Number of Participants Assessed for Adverse Events (AEs)
Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS.
Measured: reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)
Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters
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.
Measured: baseline and all study visits (Up to Week 52)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2005Jul 2008

First posted7 Mar 2005 (estimated)
Study startApr 2005
Primary completionAug 2007
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 337 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00105079
Sponsor's protocol ID: ML18413
Status last verified: Sep 2011
First submitted: 4 Mar 2005
Last updated: 2 Nov 2011
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients (GEMINI Study)
ClinicalTrials.gov ID: NCT00105079
Acronym / sponsor ID: ML18413
Conditions: HIV Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 337 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Aug 2007 (actual)
Study completion: Jul 2008 (actual)
First posted: 7 Mar 2005 (estimated)
Results: Posted 2 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
saquinavir/ritonavir	Experimental	Drug: saquinavir [Invirase], Drug: Emtricitabine/tenofovir disoproxil fumarate, Drug: Ritonavirsaquinavir 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	Active comparator	Drug: Lopinavir/ritonavir, Drug: Emtricitabine/tenofovir disoproxil fumaratelopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
saquinavir [Invirase]Also: Invirase1000 milligram (mg) Oral (po) twice daily (bid)	Drug	saquinavir/ritonavir
Lopinavir/ritonavirAlso: KaletraLopinavir/ritonavir 400/100 mg po bid	Drug	lopinavir/ritonavir
Emtricitabine/tenofovir disoproxil fumarateAlso: TruvadaEmtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd	Drug	lopinavir/ritonavir, saquinavir/ritonavir
RitonavirAlso: Norvir100 mg po bid	Drug	saquinavir/ritonavir

Primary outcome

Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
Time frame: 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.

5 secondary outcomes

Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL
Time frame: Week 48
Change From Baseline in HIV-1 RNA Viral Load
Time frame: Baseline to Week 48
Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count
Time frame: Baseline to Week 48
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)
Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters
Time frame: baseline and all study visits (Up to Week 52)

Results and safety

Results posted to the registry on 2 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saquinavir/Ritonavir	167	128
Lopinavir/Ritonavir	170	135

Primary outcome: Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL

Time frame: Week 48. Number. Unit: participants

Measure	Saquinavir/Ritonavir n = 167	Lopinavir/Ritonavir n = 170
Pts. with HIV-1 RNA Viral Load <50 copies/mL - YES	108	108
Pts. with HIV-1 RNA Viral Load <50 copies/mL - NO	59	62

Population analysed: intent-to-treat (ITT) Population

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All new nonserious AEs and SAEs, irrespective of causal relationship, were reported up to 28 days after the last dose of study treatment. Serious AEs considered related to the test drug were to be reported indefinitely. (Up to 52 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saquinavir/Ritonavir	24 of 163 (14.7%)	76 of 163 (46.6%)	Not reported
Lopinavir/Ritonavir	19 of 168 (11.3%)	92 of 168 (54.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

44 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing saquinavir [Invirase], Lopinavir/ritonavir and Emtricitabine/tenofovir disoproxil fumarate in people with HIV Infections, run by Hoffmann-La Roche at 44 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, France, Canada, Puerto Rico, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00105079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011.