Friedland G, Rainey P, Jatlow P, Andrews L, Damle B, McCance-Katz E; International Conference on AIDS.
Int Conf AIDS. 2002 Jul 7-12; 14: abstract no. TuPeB4548.
Yale University School of Medicine, New Haven CT, United States
BACKGROUND: PK interactions between HIV and substance abuse therapies may alter the distribution and efficacy / toxicity profile of each or both. Methadone alters gastric motility and may decrease bioavailability of co-administered drugs. In a previous study, pts receiving methadone with the tablet formulation of ddI (200 mg BID) were shown to have decreased ddI bioavailability. OBJECTIVE: To evaluate the relative bioavailability of ddI from encapsulated enteric coated bead formulation (EC) relative to chewable/dispersible tablet formulation in pts on chronic methadone treatment.. METHODS: A single dose 2-way crossover study in HIV negative pts on stable methadone dose. Pts randomized to EC or tablet formulation (400mg po QD) on day 1 and 2 with methadone dose and pK monitoring over 24 hrs. Alternative regimen given on day 3 and 4 with repeat pK monitoring. Toxicology screen at baseline and daily. Lab and clinical parameters followed for toxicity and opiate withdrawal. Comparisons made to historical data in non-methadone pts receiving ddI. RESULTS: Of 18 patients enrolled, 17 had evaluable data, 15 with both treatments, 1 withdrawn for non-methadone opiate detection. Pt characteristics: female (5), White (15), Hispanic (2), mean age 38 yrs; median weight 175 lbs, median methadone dose/duration, 71 mg/17 mos. CONCLUSION: This study indicates increased bioavailability from EC compared to tablet formulation in patients receiving chronic methadone treatment; there is a trend toward lowering of systemic exposure of ddI after dosing with the tablet in methadone-treated patients, consistent with previous study. EC provided plasma AUC levels comparable to historical controls in non-methadone patients. These data indicate that EC formulation of ddI can be administered to pts receiving methadone.[table: see text]
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Area Under Curve
- Biological Availability
- Chemistry, Pharmaceutical
- Cross-Over Studies
- Didanosine
- Drug Interactions
- Female
- HIV Infections
- Humans
- Methadone
- Narcotics
- Physical Therapy Modalities
- pharmacokinetics
- therapy
Other ID:
UI: 102251826
From Meeting Abstracts