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

Primary Purpose

Cachexia, HIV Infections, HIV Wasting Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dronabinol
Megestrol acetate
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cachexia focused on measuring Weight Loss, Megestrol, Cachexia, Eating Disorders, Tetrahydrocannabinol, Appetite

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Denver Public Health Dept
  • Univ of Illinois
  • Univ of Kansas School of Medicine
  • Tulane Univ Med School
  • Univ of Maryland at Baltimore / Veterans Adm
  • Washington Univ
  • SUNY / Health Sciences Ctr at Brooklyn
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Univ of Rhode Island / College of Pharmacy

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
August 22, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Roxane Laboratories, Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00000737
Brief Title
A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
Official Title
A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 1994
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Roxane Laboratories, Bristol-Myers Squibb

4. Oversight

5. Study Description

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.
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 prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival. Fifty-six patients are randomized to one of four treatment arms, as follows: high-dose megestrol acetate alone; dronabinol alone; high-dose megestrol acetate combined with dronabinol; or low-dose megestrol acetate combined with dronabinol. Treatment continues for 12 weeks. Patients are evaluated for toxicity, preliminary evidence of response (e.g., weight gain), and steady-state pharmacokinetics of drug therapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, HIV Infections, HIV Wasting Syndrome
Keywords
Weight Loss, Megestrol, Cachexia, Eating Disorders, Tetrahydrocannabinol, Appetite

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
56 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dronabinol
Intervention Type
Drug
Intervention Name(s)
Megestrol acetate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galetto G
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Egorin M
Official's Role
Study Chair
Facility Information:
Facility Name
Denver Public Health Dept
City
Denver
State/Province
Colorado
ZIP/Postal Code
802044507
Country
United States
Facility Name
Univ of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Univ of Maryland at Baltimore / Veterans Adm
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Washington Univ
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
972109951
Country
United States
Facility Name
Univ of Rhode Island / College of Pharmacy
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9071430
Citation
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.
Results Reference
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A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome

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