A Study to Compare Two Anti-HIV Drug Combinations
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00002447 |
|
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
|
Sponsor:
Hoffmann-La Roche
Information provided by:
NIH AIDS Clinical Trials Information Service
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to compare 2 anti-HIV drug combinations.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Ritonavir Drug: Efavirenz Drug: Saquinavir | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Enrollment : | 146 participants |
| 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 |
| Study Start Date : | October 1999 |
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002447
Locations
Show 26 study locations
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 |
| ClinicalTrials.gov Identifier: | NCT00002447 |
| Other Study ID Numbers: |
229R NR15720C/M61027 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | January 2001 |
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 Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Saquinavir Efavirenz |
HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors |