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A Study of Indinavir Taken With or Without DMP 266
This study has been completed.
Study NCT00002393   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002393 on ClinicalTrials.gov Archive Site
 
 
 
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

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).

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.

Phase III
Interventional
Treatment, Parallel Assignment, Efficacy Study
HIV Infections
  • Drug: Indinavir sulfate
  • Drug: Efavirenz
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
300
 
 

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.

Both
13 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT00002393
 
281A, DMP 266-020
Dupont Merck
 
 
NIH AIDS Clinical Trials Information Service
July 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP