The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
This study has been completed.
Sponsor:
Merck
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002387
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999
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Purpose
To estimate the differences in parameters of antiviral activity and safety between a control regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, HIV-1 seropositive patients.
It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that:
- The observed proportion of patients with serum viral RNA < 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks.
- The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 48 weeks.
- The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Efavirenz |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open, Randomized, Forty-Eight-Week, Pilot Study to Evaluate the Activity, Safety, and Pharmacokinetics of Indinavir Sulfate, 1200 Mg q 12h and DMP 266, 300 Mg q 12h Versus Indinavir Sulfate, 1000 Mg q 8h and DMP 266, 600 Mg q.h.s. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| Estimated Enrollment: | 80 |
It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that:
- The observed proportion of patients with serum viral RNA < 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks.
- The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 48 weeks.
- The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks.
Patients are randomized to one of two regimens: a control regimen of indinavir plus DMP 266 or an experimental regimen of indinavir plus DMP 266, each at different doses than in the control regimen.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Patients must have:
- HIV-1 seropositive status.
- CD4 count >= 100 cells/mm3.
- Serum viral RNA levels >= 10,000 copies/ml.
Exclusion Criteria
Prior Medication:
Excluded:
- Prior protease inhibitor therapy.
- Prior non-nucleoside reverse transcriptase inhibitor therapy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002387
Locations
| United States, California | |
| UCSD Treatment Ctr / Dept of Medicine & Pediatrics | |
| San Diego, California, United States, 921036329 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| United States, Colorado | |
| Univ of Colorado / Health Science Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Hawaii | |
| Hawaii AIDS Clinical Trial Unit | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Rush Med Ctr / Section of Infectious Diseases | |
| Chicago, Illinois, United States, 60612 | |
| United States, Massachusetts | |
| Beth Israel Hosp | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit | |
| Stony Brook, New York, United States, 117948153 | |
| United States, Rhode Island | |
| Brown Univ / Miriam Hosp | |
| Providence, Rhode Island, United States, 02906 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002387 History of Changes |
| Other Study ID Numbers: | 246K, 067-00 |
| 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:
|
Acquired Immunodeficiency Syndrome Drug Administration Schedule HIV Protease Inhibitors Indinavir |
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 Indinavir |
Efavirenz Reverse Transcriptase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013