Back to resultsA Study of Indinavir Taken With or Without DMP 266
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Indinavir sulfate
Efavirenz
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Placebos, Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, Reverse Transcriptase Inhibitors, efavirenz
Eligibility 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.
Sites / Locations
- Kaiser Foundation Hospital
- Med College of Georgia
- Chicago Ctr for Clinical Research
- Univ of Kentucky Med Ctr / Chandler Med Ctr
- Tulane Univ / Tulane / LSU Clinical Trials Unit
- Mount Sinai Med Ctr
- Univ of Rochester Med Ctr
- Vanderbilt Univ
- Hampton Roads Med Specialists
- Southern Alberta HIV Clinic / Foot Hills Hosp
- Ottawa Gen Hosp
- Univ of Puerto Rico School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002393
Brief Title
A Study of Indinavir Taken With or Without DMP 266
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Dupont Merck
4. Oversight
5. Study Description
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Placebos, Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, Reverse Transcriptase Inhibitors, efavirenz
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Efavirenz
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Kaiser Foundation Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Univ of Kentucky Med Ctr / Chandler Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
405360084
Country
United States
Facility Name
Tulane Univ / Tulane / LSU Clinical Trials Unit
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Vanderbilt Univ
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
372321302
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Southern Alberta HIV Clinic / Foot Hills Hosp
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Ottawa Gen Hosp
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Univ of Puerto Rico School of Medicine
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
11133370
Citation
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.
Results Reference
background
Learn more about this trial
A Study of Indinavir Taken With or Without DMP 266
We'll reach out to this number within 24 hrs