HIV InfectionsPhase 3NCT00002447
A Study to Compare Two Anti-HIV Drug Combinations
A Phase 3 study testing Ritonavir, Efavirenz and Saquinavir in people with HIV Infections, run by Hoffmann-La Roche at 26 sites in 3 countries.
Trial summary
The purpose of this study is to compare 2 anti-HIV drug combinations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ritonavir, Efavirenz and Saquinavir
- How many people
- 146 participants
- Where
- 26 sitesin 3 countries
- Study dates
- Oct 1999to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3.
- Are at least 18.
- Are able to complete the study.
Who cannot join
- Patients will not be eligible for this study if they:
- Have taken any anti-HIV medications for more than 2 weeks.
- Are pregnant or breast-feeding.
Trial locations and contacts
26 sites in 3 countries.
26 sites in 3 countries
United States22 sites
Lehigh Valley Hosp
Allentown, Pennsylvania, 18105
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
Birmingham, Alabama, 35294
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147
Burnside Clinic
Columbia, South Carolina, 29206
Nicholas Bellos
Dallas, Texas, 75246
Elmhurst Hosp
Elmhurst, New York, 11373
Associates in Research
Fort Myers, Florida, 33901
East Carolina Univ School of Medicine
Greenville, North Carolina, 27858
Greenville Hospital System
Greenville, South Carolina, 29605
Joseph Gathe
Houston, Texas, 77004
Queens Hospital Center
Jamaica, New York, 11432
St Mary's Med Ctr
Long Beach, California, 90813
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
LIJMC
New Hyde Park, New York, 11040
Saint Michael's Med Ctr / Dept of Infectious Diseases
Newark, New Jersey, 07102
Univ of Utah
Salt Lake City, Utah, 84132
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Kaiser Foundation Hospital
San Francisco, California, 94118
Univ of Washington / AIDS Clinical Trial Unit
Seattle, Washington, 98104
Infectious Disease Specialists of NJ
Union, New Jersey, 07083
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Physicans Home Service
Washington D.C., District of Columbia, 20037
Canada3 sites
Centre Hospitalier de la Universite de Montreal (CHUM)
Montreal, Quebec
Toronto Gen Hosp
Toronto, Ontario
Saint Paul's Hosp
Vancouver, British Columbia
About this study
Official title: An Open Label, Randomized, Multicenter Study to Evaluate Fortovase (Saquinavir) SGC QD, Norvir (Ritonavir) QD Plus Two NRTIs Vs Sustiva (Efavirenz) QD Plus Two NRTIs in HIV Infected Patients
The purpose of this study is to compare 2 anti-HIV drug combinations.
Read the detailed description
Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.
- Conditions
- HIV Infections
- Being tested
- Ritonavir, Efavirenz, Saquinavir
- Keywords
- Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Ritonavir, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents, efavirenz
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitonavirDrug
EfavirenzDrug
SaquinavirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startOct 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Enrolment
- 146 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- JSG Montaner, Principal investigatorAnn Collier, Study chairDanielle Rouleau, Study chairMichael Saag, Study chairPaul Volberding, Study chairSharon Walmsley, Study chairNicholas Bellos, Study chairAlfred Burnside, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002447
- Sponsor's protocol ID
- 229R
- Other IDs
- NR15720C/M61027
- Status last verified
- Jan 2001
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Multicenter Study to Evaluate Fortovase (Saquinavir) SGC QD, Norvir (Ritonavir) QD Plus Two NRTIs Vs Sustiva (Efavirenz) QD Plus Two NRTIs in HIV Infected Patients
- ClinicalTrials.gov ID
- NCT00002447
- Acronym / sponsor ID
- 229R
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Ritonavir, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents, efavirenz
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 1999
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare 2 anti-HIV drug combinations.
Detailed description
Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are HIV-positive.
- Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3.
- Are at least 18.
- Are able to complete the study.
Key exclusion criteria (3 listed)
- Have taken any anti-HIV medications for more than 2 weeks.
- Are pregnant or breast-feeding.
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 |
|---|---|---|
| Ritonavir | Drug | – |
| Efavirenz | Drug | – |
| Saquinavir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Related trials for HIV Infections
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Enrolling by invitation
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
HIV Infections
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Not yet recruitingPhase 4
Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
HIV-1 Infection
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.
JSG Montaner principal investigator
Ann Collier study chair
Danielle Rouleau study chair
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ritonavir, Efavirenz and Saquinavir in people with HIV Infections, run by Hoffmann-La Roche at 26 sites in 3 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 3 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada, Puerto Rico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 24 Jun 2005.