Status:
COMPLETED
A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Roxane Laboratories
Bristol-Myers Squibb
Conditions:
Cachexia
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain prelim...
Detailed Description
HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor pro...
Eligibility Criteria
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).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00000737
Last Update
August 25 2008
Active Locations (9)
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1
Denver Public Health Dept
Denver, Colorado, United States, 802044507
2
Univ of Illinois
Chicago, Illinois, United States, 60612
3
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
4
Tulane Univ Med School
New Orleans, Louisiana, United States, 701122699