Status:
COMPLETED
A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in HIV-positive patients w...
Detailed Description
To maximize the likelihood of a favorable response to salvage therapy, 4 or 5 drug regimens should be studied. Regimens containing fewer drugs, particularly those lacking a non-nucleoside reverse tran...
Eligibility Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
- Are over 13 years old (need consent of parent or guardian if under 18).
- Are HIV-positive.
- Currently have virologic failure (more than 1,000 copies of HIV RNA per ml).
- Agree to abstinence or use of effective birth control during the study.
- Have been taking NFV for the past 12 weeks.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a fever for 7 days or diarrhea for 30 days before study entry.
- Have a history of peripheral neuropathy within 60 days of study entry.
- Have hepatitis.
- Have any malignancy (cancer) other than minimal Kaposi's sarcoma.
- Are pregnant or breast-feeding.
- Are receiving radiation, chemotherapy, or any therapy for any illness within 14 days of study entry.
- Have taken amprenavir, saquinavir, indinavir or ritonavir for more than 7 days.
- Have received an HIV vaccine 30 days before study entry.
- Are receiving certain other medications.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
February 1 2002
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00000918
End Date
February 1 2002
Last Update
May 21 2012
Active Locations (39)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
3
UCLA CARE Ctr
Los Angeles, California, United States, 90095
4
Willow Clinic
Menlo Park, California, United States, 94025