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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz  The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
For Condition: HIV Infections
Status: Completed
Sponsor(s): Merck Research Laboratories ,
Synopsis: 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: 1. 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. 2. 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. 3. 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.
Details: It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that: 1. 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. 2. 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. 3. 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:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 80
Location and Contact Information:
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
Stony Brook, New York, 117948153
United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
United States
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Rush Med Ctr / Section of Infectious Diseases
Chicago, Illinois, 60612
United States
Beth Israel Hosp
Boston, Massachusetts, 02215
United States
Hawaii AIDS Clinical Trial Unit
Honolulu, Hawaii, 96816
United States
UCSD Treatment Ctr / Dept of Medicine & Pediatrics
San Diego, California, 921036329
United States
Additional Information:
Study ID Numbers: 246K; 067-00
Study Start Date:
Record last reviewed: June 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002387
Other Hiv Infections Studies:
1. An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir (141W94) and Abacavir Combination Therapy in Protease Inhibitor Experienced Subjects with HIV-1 Infection Who Are Failing Their Current Antiretroviral Treatment Regimen
2. A Study to Compare Three Doses of T-20 When Given in Combination with Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
3. The Safety and Effectiveness of 935U83 in HIV-Infected Patients
4. The Safety and Effectiveness of U-90152 in HIV-1 Infected Patients Who Take Zidovudine
5. An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4.
Related Studies:
Other HIV Infections Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
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