A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
1 other identifier
interventional
56
1 country
9
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 preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination. 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 prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedAugust 25, 2008
January 1, 1994
November 2, 1999
August 22, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +15 more criteria
You may not qualify if:
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Roxane Laboratoriescollaborator
- Bristol-Myers Squibbcollaborator
Study Sites (9)
Denver Public Health Dept
Denver, Colorado, 802044507, United States
Univ of Illinois
Chicago, Illinois, 60612, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699, United States
Univ of Maryland at Baltimore / Veterans Adm
Baltimore, Maryland, 21201, United States
Washington Univ
St Louis, Missouri, 63110, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951, United States
Univ of Rhode Island / College of Pharmacy
Providence, Rhode Island, 02908, United States
Related Publications (1)
Timpone JG, Wright DJ, Li N, Egorin MJ, Enama ME, Mayers J, Galetto G. The safety and pharmacokinetics of single-agent and combination therapy with megestrol acetate and dronabinol for the treatment of HIV wasting syndrome. The DATRI 004 Study Group. Division of AIDS Treatment Research Initiative. AIDS Res Hum Retroviruses. 1997 Mar 1;13(4):305-15. doi: 10.1089/aid.1997.13.305.
PMID: 9071430BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Galetto G
- STUDY CHAIR
Egorin M
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
August 25, 2008
Record last verified: 1994-01