A Study to Compare Two Anti-HIV Drug Combinations
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002447
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 2001
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Purpose
The purpose of this study is to compare 2 anti-HIV drug combinations.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Ritonavir Drug: Efavirenz Drug: Saquinavir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| Estimated Enrollment: | 146 |
| Study Start Date: | October 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002447
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Hide Study LocationsLocations
| United States, Alabama | |
| Univ of Alabama at Birmingham / AIDS Outpatient Clinic | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| St Mary's Med Ctr | |
| Long Beach, California, United States, 90813 | |
| Kaiser Foundation Hospital | |
| San Francisco, California, United States, 94118 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| Physicans Home Service | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Associates in Research | |
| Fort Myers, Florida, United States, 33901 | |
| Univ of Miami / Jackson Memorial Hosp | |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| Illinois Masonic Med Ctr | |
| Chicago, Illinois, United States, 606575147 | |
| United States, New Jersey | |
| Saint Michael's Med Ctr / Dept of Infectious Diseases | |
| Newark, New Jersey, United States, 07102 | |
| Infectious Disease Specialists of NJ | |
| Union, New Jersey, United States, 07083 | |
| United States, New York | |
| Elmhurst Hosp | |
| Elmhurst, New York, United States, 11373 | |
| Queens Hospital Center | |
| Jamaica, New York, United States, 11432 | |
| LIJMC | |
| New Hyde Park, New York, United States, 11040 | |
| United States, North Carolina | |
| East Carolina Univ School of Medicine | |
| Greenville, North Carolina, United States, 27858 | |
| United States, Pennsylvania | |
| Lehigh Valley Hosp | |
| Allentown, Pennsylvania, United States, 18105 | |
| United States, South Carolina | |
| Burnside Clinic | |
| Columbia, South Carolina, United States, 29206 | |
| Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Texas | |
| Nicholas Bellos | |
| Dallas, Texas, United States, 75246 | |
| Joseph Gathe | |
| Houston, Texas, United States, 77004 | |
| United States, Utah | |
| Univ of Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| Univ of Washington / AIDS Clinical Trial Unit | |
| Seattle, Washington, United States, 98104 | |
| Canada, British Columbia | |
| Saint Paul's Hosp | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Toronto Gen Hosp | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Centre Hospitalier de la Universite de Montreal (CHUM) | |
| Montreal, Quebec, Canada | |
| Puerto Rico | |
| Ponce Univ Hosp | |
| Ponce, Puerto Rico, 00731 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Principal Investigator: | JSG Montaner | |
| Study Chair: | Ann Collier | |
| Study Chair: | Danielle Rouleau | |
| Study Chair: | Michael Saag | |
| Study Chair: | Paul Volberding | |
| Study Chair: | Sharon Walmsley | |
| Study Chair: | Nicholas Bellos | |
| Study Chair: | Alfred Burnside | |
| Study Chair: | Stephen Follansbee | |
| Study Chair: | Joseph Gathe | |
| Study Chair: | Bruce Hathaway | |
| Study Chair: | Margaret Hoffman-Terry | |
| Study Chair: | Jazila Mantis | |
| Study Chair: | Joseph Masci | |
| Study Chair: | Mahmoud Mustafa | |
| Study Chair: | John Schrank | |
| Study Chair: | Malte Schutz | |
| Study Chair: | Leon Smith |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002447 History of Changes |
| Other Study ID Numbers: | 229R, NR15720C/M61027 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Drug Therapy, Combination Saquinavir HIV Protease Inhibitors Ritonavir |
Dosage Forms Reverse Transcriptase Inhibitors Anti-HIV Agents efavirenz |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases HIV Protease Inhibitors Saquinavir |
Ritonavir Reverse Transcriptase Inhibitors Efavirenz Anti-HIV Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013