Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir
2 other identifiers
interventional
120
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hiv-infections
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, 90033, United States
Yale Univ / AIDS Clinical Trials Unit
New Haven, Connecticut, 06510, United States
Med Ctr of Delaware
Wilmington, Delaware, 19899, United States
Hawaii AIDS Clinical Trial Unit
Honolulu, Hawaii, 96816, United States
Rush Presbyterian Saint Lukes Med Ctr
Chicago, Illinois, 606123832, United States
Johns Hopkins Hosp
Baltimore, Maryland, 212876220, United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114, United States
Columbia Presbyterian Hosp
New York, New York, 10032, United States
AIDS TMT Unit / Univ Hosp
Stony Brook, New York, 117948153, United States
Vanderbilt Clinic
Nashville, Tennessee, 37212, United States
Oaklawn Physicians Group
Dallas, Texas, 75219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-06