Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir

Completed · Phase 3

Conditions studied: HIV Infections

In brief

The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.

Key facts

Study ID

NCT00002220

Run by

Merck Sharp & Dohme LLC

People needed

120

Last updated by the study team

2005-06-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• Serologically documented HIV infection.
• Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.
• Parental consent for patients under 18.
• Nelfinavir-Failure Group:
• Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.
• Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).
• Control Group:
• Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.
• Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.

You may not qualify if…

• Prior Medication:
• Excluded:
• Control group:
• Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.
• Required:
• Nelfinavir-failure patients:
• At least 16 weeks of nelfinavir.
• Control group:
• At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.

Where it is running

• LAC / USC Med Ctr / Infectious Diseases — Los Angeles, California, United States
• Yale Univ / AIDS Clinical Trials Unit — New Haven, Connecticut, United States
• Med Ctr of Delaware — Wilmington, Delaware, United States
• Hawaii AIDS Clinical Trial Unit — Honolulu, Hawaii, United States
• Rush Presbyterian Saint Lukes Med Ctr — Chicago, Illinois, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Massachusetts Gen Hosp — Boston, Massachusetts, United States
• Columbia Presbyterian Hosp — New York, New York, United States
• AIDS TMT Unit / Univ Hosp — Stony Brook, New York, United States
• Vanderbilt Clinic — Nashville, Tennessee, United States
• Oaklawn Physicians Group — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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