A Study of Indinavir Taken With or Without DMP 266

D

Dupont Merck

Status and phase

Completed
Phase 3

Conditions

HIV Infections

Treatments

Drug: Indinavir sulfate
Drug: Efavirenz

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002393
DMP 266-020
281A

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

13 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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