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Home > "A" Clinical Trials Conditions > A Study of Azidothymidine Plus Methadone in Patients with AIDS and AIDS Related Complex (ARC)  A Study of Azidothymidine Plus Methadone in Patients with AIDS and AIDS Related Complex (ARC)
A Study of Azidothymidine Plus Methadone in Patients with AIDS and AIDS Related Complex (ARC)
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine if methadone treatment will affect the blood levels of zidovudine (AZT) in patients with AIDS or AIDS-related complex (ARC) who are receiving oral AZT and methadone therapy. In addition, the blood levels of methadone both before and during AZT treatment will be studied, and patients receiving daily oral methadone treatment will be evaluated for signs of narcotic withdrawal during treatment with AZT. The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT. Therefore, the study of potential drug interactions is essential.
Details: The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT. Therefore, the study of potential drug interactions is essential. The 18 patients are patients with AIDS or ARC. Nine are control patients who are not receiving methadone and are not IV drug abusers. Nine are former IV drug abusers who have been maintained on methadone for at least 6 months and who have been receiving a constant daily dose of methadone for at least 1 month. Plasma and urine levels of methadone are determined over a 4 hour period. The dose of AZT: For the pharmacokinetic study of AZT, plasma and urine samples are taken after oral dose of AZT and an intravenous dose of AZT in the control and methadone groups.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Prior Medication: Allowed: - Oral nonabsorbable antifungal agents. The study will include 18 patients with AIDS or HIV-related symptomatic illness as defined by the CDC classification group IVa and c2. Of these, 9 methadone recipients will have been maintained on methadone for at least 1 month and will have received a constant daily dose of 30-90 mg of methadone for at least 10 days. Nine patients will be former intravenous drug abusers. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Temperature > 101 degrees F. - Ascites. - Active opportunistic infection. Concurrent Medication: Excluded: - Other inducers or inhibitors of hepatic microsomal enzymes. - Any chronic systemic medications. Patients with the following symptoms or conditions are excluded: - Temperature > 101 degrees F. - Ascites. - Active opportunistic infection. Prior Medication: Excluded within 72 hours of study entry: - All medication except oral nonabsorbable antifungal agents. - Excluded within 2 weeks of study entry: - Any other experimental drug. - Drugs with known nephrotoxic potential or drugs known to cause neutropenia. - Rifampin or its derivatives, phenytoin, or barbiturates. Active drug or alcohol abuse.
Total Enrollment: 18
Location and Contact Information:
Overall Study Official:
GFriedland, Study Chair,
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Additional Information:
Study ID Numbers: ACTG 055;
Study Start Date:
Record last reviewed: August 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001008
Other Hiv Infections Studies:
1. A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
2. Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients with HIV and Hepatitis C Virus
3. Genetic Markers for Focal Segmental Glomerulosclerosis
4. Safety and Effectiveness of 3 Anti-HIV Treatments in Patients Who Have Failed Previous Treatments Containing Nelfinavir
5. The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients with AIDS-Related Lymph Node Cancer
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A Study of Azidothymidine Plus Methadone in Patients with AIDS and AIDS Related Complex (ARC)
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