A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome

Inclusion Criteria Concurrent Medication: Allowed: * Zidovudine (AZT), didanosine (ddI), and dideoxycytidine (ddC). If initiating new antiretroviral therapy, patient must have been on a stable dose for at least 4 weeks prior to study entry. * Maintenance or suppressive therapy with any of the following, provided patient has been on a stable dose for at least 1 week prior to study entry: * Ganciclovir or foscarnet for CMV retinitis. * Fluconazole, amphotericin B, or flucytosine for cryptococcosis. * Amphotericin B for disseminated histoplasmosis. * Pyrimethamine, sulfadiazine, dapsone, or clindamycin for toxoplasmosis. * Amikacin, clarithromycin, clofazimine, ethambutol, ciprofloxacin, or rifampin for disseminated Mycobacterium avium complex. * Isoniazid, rifampin, ethambutol, or pyrazinamide for M. tuberculosis. * Any of the following provided patient is on a stable dose for at least 1 week prior to study entry: * Trimethoprim-sulfamethoxazole, aerosolized pentamidine, or dapsone for Pneumocystis carinii prophylaxis. * Clotrimazole troches, nystatin suspension, ketoconazole, or fluconazole for oral candidiasis. * Oral acyclovir for mucocutaneous herpes simplex. * Narcotic analgesics, tranquilizers, sedative-hypnotics, or anticholinergic agents provided patient is on a stable dose for at least 1 week prior to study entry. Patients must have: * HIV infection. * HIV-wasting syndrome and anorexia. * Life expectancy of at least 4 months. * Ability to tolerate oral therapy, feed themselves, and have access to as much food as they desire with no dietary restrictions. Prior Medication: Allowed: * Prior zidovudine (AZT), didanosine (ddI), and dideoxycytidine (ddC). * Prior maintenance or suppressive therapy for certain opportunistic infections, as follows: * Ganciclovir or foscarnet for CMV retinitis. * Fluconazole, amphotericin B, or flucytosine for cryptococcosis. * Amphotericin B for disseminated histoplasmosis. * Pyrimethamine, sulfadiazine, dapsone, or clindamycin for toxoplasmosis. * Amikacin, clarithromycin, clofazimine, ethambutol, ciprofloxacin, or rifampin for disseminated Mycobacterium avium complex. * Isoniazid, rifampin, ethambutol, or pyrazinamide for M. tuberculosis. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Major, acute opportunistic infections. * Active neoplasms other than Kaposi's sarcoma or localized skin carcinoma. * Diabetes, congestive heart failure, clinical ascites, or uncontrolled hypertension. * Persistent grade 3/4 diarrhea. * Impaired oral intake, such as occurs with Candida esophagitis or severe mouth ulcers. * Clinically significant cardiac arrhythmias. * Requirement for anticonvulsants for seizure disorder. Concurrent Medication: Excluded: * Marijuana use. * Anabolic steroids. * Anticonvulsants for seizure disorders. * Alcohol or barbiturates. Patients with the following prior conditions are excluded: * Diagnosis of a major, acute opportunistic infection within 2 months prior to study entry. * Hospitalization within 2 weeks prior to study entry. * History of hypersensitivity reactions to megestrol acetate, dronabinol, or sesame oil (a component of the dronabinol capsules). * History of thromboembolic events. * History of psychiatric disorder other than depression. Prior Medication: Excluded: * Prior dronabinol. * Megestrol acetate within 2 months prior to study entry. * Marijuana within 1 month prior to study entry. * Anabolic steroids within 3 months prior to study entry. Current drug or alcohol abuse (patients with a history of occasional marijuana use are eligible provided they have abstained from its use for 1 month prior to study entry and agree to refrain from marijuana use for the study period).