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Home > "A" Clinical Trials Conditions > A Study of Indinavir Taken with or without DMP 266  A Study of Indinavir Taken with or without DMP 266
A Study of Indinavir Taken with or without DMP 266
For Condition: HIV Infections
Status: Completed
Sponsor(s): Dupont Merck ,
Synopsis: The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).
Details: In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows: Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks, patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion. After the completion of the 24-week period, patients have the option to continue on open-label DMP 266 and indinavir.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 13 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - CD4+ cell count of at least 50 cells/mm3. - HIV RNA level of at least 10,000 copies/ml by reverse transcriptase polymerase chain reaction (RT-PCR, Amplicor test kit) at screening. - Signed, informed consent from parent or legal guardian for patients less than 18 years of age. Exclusion Criteria Prior Medication: Excluded: - DMP 266. - Other nonnucleoside reverse transcriptase inhibitors. Required: One or two NRTIs (except ZDV and d4T in combination) for a minimum of 8 weeks, within 12 weeks prior to screening.
Total Enrollment: 300
Location and Contact Information:
Ottawa Gen Hosp
Ottawa, Ontario,
Canada
Vanderbilt Univ
Nashville, Tennessee, 372321302
United States
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, 70122
United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
United States
Kaiser Foundation Hospital
San Francisco, California, 94118
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Southern Alberta HIV Clinic / Foot Hills Hosp
Calgary, Alberta,
Canada
Univ of Kentucky Med Ctr / Chandler Med Ctr
Lexington, Kentucky, 405360084
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Puerto Rico School of Medicine
San Juan, , 00927
Puerto Rico
Additional Information:
Study ID Numbers: 281A; DMP 266-020
Study Start Date:
Record last reviewed: July 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002393
Other Hiv Infections Studies:
1. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants
2. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months
3. A Prospective Double-Blind Study of Retrovir in Early HIV Infection
4. Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV
5. Study of Total Body Irradiation in Combination With Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation Followed By Cyclosporine and Mycophenolate Mofetil in High Risk-Patients With Human Immunodeficiency Virus-1
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A Study of Indinavir Taken with or without DMP 266
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