Effect of ritonavir/saquinavir on stereoselective pharmacokinetics of methadone: results of AIDS Clinical Trials Group (ACTG) 401.
J G Gerber, S Rosenkranz, Y Segal...
https://pubmed.ncbi.nlm.nih.gov/11404537Completed
Phase 1
Age: 18Years +
All Genders
ID00000906
The Effect of HIV Protease Inhibitors on the Stereospecific Metabolism of Methadone in HIV-Infected Subjects
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
12
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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. This study will measure the interactions between methadone and the PIs. Methadone is used treat addicts and to treat severe pain. In order to find the safest way to use methadone with PIs, it is important to evaluate how they interact.
CONDITIONS
Official Title
Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 7 locations
1
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
2
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
3
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
4
Beth Israel Med Ctr
New York, New York, United States, 10003
Status Unknown
5
Chelsea Ctr
New York, New York, United States, 10021
Status Unknown
6
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
7
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
Similar Trials
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here