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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002447 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Efficacy 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 |
| 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 |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
Contacts and Locations
Show 26 Study Locations| 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: | Jazila Mantis | |
| Study Chair: | Joseph Masci | |
| Study Chair: | Mahmoud Mustafa | |
| Study Chair: | John Schrank | |
| Study Chair: | Malte Schutz | |
| Study Chair: | Leon Smith |
More Information
| Study ID Numbers: | 229R, NR15720C/M61027 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002447 |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Saquinavir HIV Protease Inhibitors Ritonavir |
Dosage Forms Reverse Transcriptase Inhibitors Anti-HIV Agents efavirenz |
|
Virus Diseases Efavirenz Sexually Transmitted Diseases, Viral Saquinavir Ritonavir |
HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |
