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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Page 1 of 2 (7 locations)

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

Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients | DecenTrialz