OBJECTIVE: To examine the effect of dronabinol (delta-9-tetrahydrocann
abinol) on appetite and nutritional status in patients with symptomati
c HIV infection and weight loss. DESIGN: Double-blind, randomized, pla
cebo-controlled, crossover trial with two five-week treatment periods
separated by a two-week washout period. Patients received dronabinol 5
mg twice daily before meals or placebo. SETTING: A university-based H
IV/AIDS clinic and a large infectious disease private practice largely
devoted to care of patients with HIV. PARTICIPANTS: Twelve HIV-infect
ed patients who had had at least a 2.25-kg weight loss participated in
the study. Five patients completed the protocol, and seven withdrew (
two because of drug intolerance, two because of disease progression, t
wo because of noncompliance, and one because of experimental antiretro
viral therapy). MAIN OUTCOME MEASURES: Main outcome measures included
caloric intake, weight, percent body fat, serum prealbumin, and sympto
m distress. RESULTS: During dronabinol treatment, subjects experienced
increased percent body fat (one percent, p=0.04); decreased symptom d
istress (p=0.04); and trends toward weight gain (0.5 kg, p=0.13), incr
eased prealbumin (29.0 mg/L, p=0.11), and improved appetite score (p=0
.14). CONCLUSIONS: In a selected group of HIV-infected patients with w
eight loss, short-term treatment with dronabinol may result in improve
ment in nutritional status and symptom distress.