A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors

Completed · Phase 2

Conditions studied: HIV Infections

In brief

Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).

Key facts

Study ID

NCT00002235

Run by

Merck Sharp & Dohme LLC

People needed

6

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• You may be eligible for this study if you:
• Are HIV-positive.
• Are at least 13 years old (consent of parent or guardian required if under 18).
• Have a viral load of at least 10,000 copies/ml within 30 days of study entry.
• Agree to use a barrier method of birth control, such as condoms, during the study.

You may not qualify if…

• You will not be eligible for this study if you:
• Have hepatitis.
• Have any other serious medical condition besides HIV infection.
• Are allergic to indinavir, nelfinavir, or efavirenz.
• Have ever taken NNRTIs or protease inhibitors.
• Have had chemotherapy or radiation therapy within 30 days of study entry. (Local radiation therapy is allowed.)
• Have taken certain other medications that might affect your immune system such as interleukin-2, interferon, or a vaccine within 30 days of study entry.
• Are enrolled or plan to enroll in another anti-HIV drug study during this study.
• Are pregnant or breast-feeding.
• Abuse alcohol or drugs.

Where it is running

• Pacific Oaks Med Group — Beverly Hills, California, United States
• Univ of Colorado / Health Science Ctr — Denver, Colorado, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Brown Univ School of Medicine — Providence, Rhode Island, United States
• Hampton Roads Med Specialists — Hampton, Virginia, United States

Full record on ClinicalTrials.gov

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