- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002387
The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 921036329
- UCSD Treatment Ctr / Dept of Medicine & Pediatrics
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San Francisco, California, United States, 94110
- San Francisco Gen Hosp
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Colorado
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Denver, Colorado, United States, 80262
- Univ of Colorado / Health Science Ctr
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Hawaii
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Honolulu, Hawaii, United States, 96816
- Hawaii AIDS Clinical Trial Unit
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Med Ctr / Section of Infectious Diseases
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Hosp
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New York
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Stony Brook, New York, United States, 117948153
- Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Brown Univ / Miriam Hosp
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Indinavir
- Efavirenz
Other Study ID Numbers
- 246K
- 067-00
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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