A Study of Indinavir Taken With or Without DMP 266

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00002393

Run by

Dupont Merck

People needed

300

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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