|
Methadone Effects on Zidovudine (ZDV, AZT) Disposition Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Methadone Effects on Zidovudine (ZDV, AZT) Disposition conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Methadone Effects on Zidovudine (ZDV, AZT) Disposition Clinical research trials and Methadone Effects on Zidovudine (ZDV, AZT) Disposition healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Methadone Effects on Zidovudine (ZDV, AZT) Disposition. Methadone Effects on Zidovudine (ZDV, AZT) Disposition Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Methadone Effects on Zidovudine (ZDV, AZT) Disposition clinical trial. Participants typically obtain the most effective healthcare available for their Methadone Effects on Zidovudine (ZDV, AZT) Disposition condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Methadone Effects on Zidovudine (ZDV, AZT) Disposition  Methadone Effects on Zidovudine (ZDV, AZT) Disposition
Methadone Effects on Zidovudine (ZDV, AZT) Disposition
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: To determine whether methadone maintenance alters the pharmacokinetics of zidovudine (AZT). To determine whether any such effect of methadone on disposition of AZT is time dependent and whether a metabolic interaction between AZT and methadone exists. Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination.
Details: Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination. After 6 days of inpatient detoxification with clonidine, patients addicted to opiates are randomized to receive either oral or intravenous AZT for the first dose, followed by determination of plasma and urine pharmacokinetics. On the second day of AZT dosing, the alternate form of administration will be used for the first dose. On both days, all other doses are given orally. Patients then begin methadone maintenance in combination with AZT for 7 days of inpatient treatment, with further pharmacokinetic sampling. After hospitalization for 16 days total, patients continue AZT/methadone treatment on an outpatient basis, and then 2 months later are readmitted as inpatients for 5 days for further pharmacokinetic sampling. Control patients who are not addicted to opiates are hospitalized for 3 days at study entry and are randomized for AZT treatment and pharmacokinetic sampling in the same manner as the first group, although they will not receive methadone treatment. Control patients are readmitted for 2 days after 1 week of AZT treatment and then again after 59 days of AZT treatment.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - CD4 count 100 - 500 cells/mm3. - No active opportunistic infection or wasting syndrome. - Opiate addiction or prior enrollment in a methadone treatment program (methadone recipients only). - Admission to General Clinical Research Center at Yale-New Haven Hospital for clonidine detoxification (methadone recipients only). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Inadequate IV access. - Benzodiazepine abuse. Concurrent Medication: Excluded: - Amiodarone. - Anesthetics, general. - Azithromycin. - Barbiturates. - Carbamazepine. - Cimetidine. - Ciprofloxacin. - Clarithromycin. - Dexamethasone. - Disulfiram. - Erythromycin. - Fluoroquinolones. - Fluoxetine. - Gestodene. - Hydrochlorothiazide. - Hypoglycemics, oral. - Isoniazid. - Itraconazole. - Ketoconazole. - Levomepromazine. - MAO inhibitors. - Methoxsalen. - Nafcillin. - Narcotic analgesics. - Naringenin. - Norethindrone. - Omeprazole. - Pentazocine. - Phenothiazines. - Phenytoin. - Quinidine. - Ranitidine. - Rifabutin. - Rifampin. - Sedative Hypnotics. - Sulfaphenazole. - Tranquilizers (except at discretion of investigator and protocol chair). - Tricyclic antidepressants. - Troleandomycin. - Warfarin. Prior Medication: Excluded within 4 weeks prior to study entry: - Rifampin or its derivatives. - Phenytoin. - Barbiturates. - Cimetidine. - Other drugs known to induce or inhibit hepatic microsomal enzymes. Excluded within 14 days prior to study entry: - Any other experimental drug. - Drugs with known nephrotoxic potential. Excluded within 72 hours prior to study entry: - Amiodarone. - Anesthetics, general. - Azithromycin. - Carbamazepine. - Ciprofloxacin. - Clarithromycin. - Dexamethasone. - Disulfiram. - Erythromycin. - Fluoroquinolones. - Fluoxetine. - Gestodene. - Hydrochlorothiazide. - Hypoglycemics, oral. - Isoniazid. - Itraconazole. - Ketoconazole. - Levomepromazine. - MAO inhibitors. - Methoxsalen. - Nafcillin. - Narcotic analgesics. - Naringenin. - Norethindrone. - Omeprazole. - Pentazocine. - Phenothiazines. - Quinidine. - Ranitidine. - Rifabutin. - Sedative Hypnotics. - Sulfaphenazole. - Tranquilizers (except at discretion of investigator and protocol chair). - Tricyclic antidepressants. - Troleandomycin. - Warfarin. Continued active drug or alcohol abuse or dependence that would decrease the probability of study completion.
Total Enrollment: 15
Location and Contact Information:
Overall Study Official:
JatlowP, Study Chair,
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Additional Information:
Study ID Numbers: ACTG 262;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000800
Other Hiv Infections Studies:
1. A Study of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
2. A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV Vaccines
3. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
4. A Study of DTC in Patients With AIDS and AIDS Related Complex
5. A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
Related Studies:
Other HIV Infections Clinical Trials
Other Connecticut Clinical Trials
Other New Haven Clinical Trials
Methadone Effects on Zidovudine (ZDV, AZT) Disposition
|
|
|
|
|
|
|
|
