Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
300 participants
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PARALLEL
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Indinavir sulfate
Efavirenz
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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.
13 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dupont Merck
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kaiser Foundation Hospital
San Francisco, California, United States
Med College of Georgia
Augusta, Georgia, United States
Chicago Ctr for Clinical Research
Chicago, Illinois, United States
Univ of Kentucky Med Ctr / Chandler Med Ctr
Lexington, Kentucky, United States
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, United States
Mount Sinai Med Ctr
New York, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
Vanderbilt Univ
Nashville, Tennessee, United States
Hampton Roads Med Specialists
Hampton, Virginia, 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, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DMP 266-020
Identifier Type: -
Identifier Source: secondary_id
281A
Identifier Type: -
Identifier Source: org_study_id