Status:
COMPLETED
Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see if it is safe to combine methadone with two HIV protease inhibitors (PIs), ritonavir (RTV) and saquinavir (SQV), in HIV-infected patients not currently taking PIs. ...
Detailed Description
Methadone is extensively used in the maintenance treatment of addicts and in the management of severe pain. In order to use methadone with HIV protease inhibitors correctly, it is important to evaluat...
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive and have an HIV RNA count below 100,000 copies/ml within 30 days prior to study entry.
- Are taking methadone.
- Are at least 18 years old.
- Are within 40% of your ideal body weight and weigh at least 99 lbs.
Exclusion Criteria
You will not be eligible for this study if you:
- Are allergic to or are unable to take RTV or SQV.
- Have a history of treatment failure with indinavir, RTV, or SQV.
- Have a history of certain illnesses that might prevent you from completing the study.
- Have severe diarrhea or other stomach problems.
- Have taken any PI within 4 weeks prior to study entry.
- Would be unable to complete the study due to alcohol or drug abuse.
- Are co-enrolled in other protocols that have you taking medications that are prohibited in this study.
- Are taking PIs other than RTV or SQV.
- Are receiving certain therapies or are taking certain medications, including experimental drugs.
- Have an active opportunistic (AIDS-related) infection or disease that requires medication within 14 days prior to study entry.
- Are pregnant or breast-feeding.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 2000
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00000906
End Date
September 1 2000
Last Update
November 4 2021
Active Locations (7)
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1
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
2
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
3
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
4
Beth Israel Med Ctr
New York, New York, United States, 10003