A Study of Indinavir Taken With or Without DMP 266
A Phase III, Double-Blind, Placebo-Controlled, Multicenter Study to Determine the Effectiveness and Tolerability of the Combination of DMP 266 and Indinavir Versus Indinavir in HIV-Infected Patients Receiving Nucleoside Analogue (NRTI) Therapy
2 other identifiers
interventional
300
3 countries
12
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
July 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dupont Mercklead
Study Sites (12)
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
Med College of Georgia
Augusta, Georgia, 30912, United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610, United States
Univ of Kentucky Med Ctr / Chandler Med Ctr
Lexington, Kentucky, 405360084, United States
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, 70122, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
Vanderbilt Univ
Nashville, Tennessee, 372321302, United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666, United States
Southern Alberta HIV Clinic / Foot Hills Hosp
Calgary, Alberta, Canada
Ottawa Gen Hosp
Ottawa, Ontario, Canada
Univ of Puerto Rico School of Medicine
San Juan, 00927, Puerto Rico
Related Publications (1)
Haas DW, Fessel WJ, Delapenha RA, Kessler H, Seekins D, Kaplan M, Ruiz NM, Ploughman LM, Labriola DF, Manion DJ. Therapy with efavirenz plus indinavir in patients with extensive prior nucleoside reverse-transcriptase inhibitor experience: a randomized, double-blind, placebo-controlled trial. J Infect Dis. 2001 Feb 1;183(3):392-400. doi: 10.1086/318083. Epub 2000 Dec 29.
PMID: 11133370BACKGROUND