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A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss

Primary Purpose

HIV Infections, HIV Wasting Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Testosterone enanthate
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 HIV Infections focused on measuring Placebos, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Wasting Syndrome, Megestrol Acetate, dihydrotestosterone heptanoate

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Stable antiretroviral therapy provided the patient has been on it for >=30 days prior to study entry. AS PER AMENDMENT 9/26/97: Optimized antiretroviral therapy as determined by primary care provider with at least 30 days since initiation of such therapy. Standard maintenance and prophylaxis therapy for opportunistic infections is permitted provided patients have been on a stable dosage regimen for 2 weeks prior to screening. G-CSF. Erythropoietin. Any symptomatic therapy (e.g., analgesics, antihistamines, antiemetic, antidiarrheal agents, etc.). Replacement levels of thyroid drugs (same drug and dose as at 30 days pre-entry). Maintenance therapy is permitted for chronic opportunistic infections, but patient must be on a stable regimen for 14 days pre-entry. AS PER AMENDMENT 9/26/97: Oral nutritional supplements, dronabinol, cyproheptadine, or pentoxifylline. Patients must have: Documented HIV-1 infection. Documented weight loss of > 10% pre-illness weight or Body Mass Index < 18.5 kg/m2. AS PER AMENDMENT 9/26/97: Documented weight loss of >= 5% pre-illness weight or Body Mass Index < 20 kg/m2. Life expectancy of at least 6 months. NOTE: This protocol meets federal requirements governing prisoner participation in clinical trials. Prior Medication: Allowed: Stable (no change in drugs or dosage) antiretroviral therapy or no antiretroviral medications for >= 30 days prior to the study entry. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Diabetes mellitus. Diarrhea defined as 4 or more liquid or watery stools per day while using antidiarrheal medication. Tube feeding. AS PER AMENDMENT 9/26/97: Total or partial parenteral nutrition delivered centrally or peripherally. Impaired oral intake due to mucositis of any cause. Grade 2 or greater intractable nausea and vomiting despite medication. Cardiomyopathy or congestive heart failure. Persistent palpable dominant breast mass at study entry that has not been worked up - males and females. Female patients: Pap smear or cervical biopsy that demonstrates high grade squamous intraepithelial lesions or cervical intraepithelial lesions 2 or worse. Concurrent Medication: Excluded: Systemic chemotherapy for B-cell lymphoma or malignancies other than Kaposi's sarcoma. (Patients with Kaposi's sarcoma receiving systemic chemotherapy will not be excluded.) Total or peripheral parenteral nutrition (oral supplements are not excluded). Anticoagulant therapy. Any drug that is designed to affect appetite or weight gain. AS PER AMENDMENT 9/26/97: Initiation of any new therapy designed to promote weight gain. Any change of antiretroviral or any change in the dosage of antiretroviral/s that had not been started 30 days pre-entry. AS PER AMENDMENT 9/26/97: Initiation of antiretroviral therapy within 12 weeks of protocol therapy for patients not previously receiving antiretroviral therapy. Anabolic hormones. Systemic glucocorticoids. Cytokine inhibitors. Oral contraceptives. Cytokines. Ketoconazole. Any other medication that might interfere with the objectives of this study. AS PER AMENDMENT 9/26/97:DHEA. Patients with the following prior conditions will be excluded: Acute systemic opportunistic infections within 30 days prior to entry. Weight gain >= 3% as documented by self reporting or clinical records during the preceding 4 weeks. AS PER AMENDMENT 9/26/97: Enrollment of such patients should be deferred until weight stabilizes. History of hypersensitivity reaction to megestrol acetate or testosterone enanthate. History of cardiomyopathy or congestive heart failure. Female patients: History of invasive cervical cancer. AS PER AMENDMENT 9/26/97: History of thromboemboli. Prior Medication: Excluded: No testosterone treatment within the previous 8 weeks. Excluded within 30 days prior to entry: Ketoconazole. Initiation or change in antiretroviral therapy. Interleukins. Interferon, anabolic, hormonal or experimental therapies designed to improve appetite or weight gain (e.g., thalidomide, dronabinol, megestrol acetate, cyproheptadine, anabolic steroids, systemic glucocorticoids, pentoxifylline, or growth hormone). AS PER AMENDMENT 9/26/97: Dehydroepiandrosterone (DHEA).

Sites / Locations

  • USC CRS
  • UCLA CARE Center CRS
  • Ucsf Aids Crs
  • University of Colorado Hospital CRS
  • Howard University Hosp., Div. of Infectious Diseases, ACTU
  • Queens Med. Ctr.
  • Univ. of Hawaii at Manoa, Leahi Hosp.
  • Northwestern University CRS
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • Indiana Univ. School of Medicine, Wishard Memorial
  • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
  • Johns Hopkins Adult AIDS CRS
  • Beth Israel Deaconess Med. Ctr., ACTG CRS
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Washington U CRS
  • Beth Israel Med. Ctr. (Mt. Sinai)
  • Cornell University A2201
  • Memorial Sloan-Kettering Cancer Ctr.
  • Duke Univ. Med. Ctr. Adult CRS
  • Univ. of Cincinnati CRS
  • Hosp. of the Univ. of Pennsylvania CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001079
Brief Title
A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
Official Title
Double-Blind Randomized Comparison Phase II Trial of Megestrol Acetate and Testosterone Enanthate in Combination Versus Megestrol Acetate Plus Testosterone Enanthate Placebo in Human Immunodeficiency Virus (HIV)-Associated Wasting.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM) that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination. Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.
Detailed Description
Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism. This is a 24 week study consisting of a 12 week double blind, randomized comparison Phase II trial of megestrol acetate and testosterone enanthate in combination versus megestrol acetate plus testosterone enanthate placebo in HIV associated wasting and a 12 week open label follow up of the combination therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Wasting Syndrome
Keywords
Placebos, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Wasting Syndrome, Megestrol Acetate, dihydrotestosterone heptanoate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Testosterone enanthate
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: Stable antiretroviral therapy provided the patient has been on it for >=30 days prior to study entry. AS PER AMENDMENT 9/26/97: Optimized antiretroviral therapy as determined by primary care provider with at least 30 days since initiation of such therapy. Standard maintenance and prophylaxis therapy for opportunistic infections is permitted provided patients have been on a stable dosage regimen for 2 weeks prior to screening. G-CSF. Erythropoietin. Any symptomatic therapy (e.g., analgesics, antihistamines, antiemetic, antidiarrheal agents, etc.). Replacement levels of thyroid drugs (same drug and dose as at 30 days pre-entry). Maintenance therapy is permitted for chronic opportunistic infections, but patient must be on a stable regimen for 14 days pre-entry. AS PER AMENDMENT 9/26/97: Oral nutritional supplements, dronabinol, cyproheptadine, or pentoxifylline. Patients must have: Documented HIV-1 infection. Documented weight loss of > 10% pre-illness weight or Body Mass Index < 18.5 kg/m2. AS PER AMENDMENT 9/26/97: Documented weight loss of >= 5% pre-illness weight or Body Mass Index < 20 kg/m2. Life expectancy of at least 6 months. NOTE: This protocol meets federal requirements governing prisoner participation in clinical trials. Prior Medication: Allowed: Stable (no change in drugs or dosage) antiretroviral therapy or no antiretroviral medications for >= 30 days prior to the study entry. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Diabetes mellitus. Diarrhea defined as 4 or more liquid or watery stools per day while using antidiarrheal medication. Tube feeding. AS PER AMENDMENT 9/26/97: Total or partial parenteral nutrition delivered centrally or peripherally. Impaired oral intake due to mucositis of any cause. Grade 2 or greater intractable nausea and vomiting despite medication. Cardiomyopathy or congestive heart failure. Persistent palpable dominant breast mass at study entry that has not been worked up - males and females. Female patients: Pap smear or cervical biopsy that demonstrates high grade squamous intraepithelial lesions or cervical intraepithelial lesions 2 or worse. Concurrent Medication: Excluded: Systemic chemotherapy for B-cell lymphoma or malignancies other than Kaposi's sarcoma. (Patients with Kaposi's sarcoma receiving systemic chemotherapy will not be excluded.) Total or peripheral parenteral nutrition (oral supplements are not excluded). Anticoagulant therapy. Any drug that is designed to affect appetite or weight gain. AS PER AMENDMENT 9/26/97: Initiation of any new therapy designed to promote weight gain. Any change of antiretroviral or any change in the dosage of antiretroviral/s that had not been started 30 days pre-entry. AS PER AMENDMENT 9/26/97: Initiation of antiretroviral therapy within 12 weeks of protocol therapy for patients not previously receiving antiretroviral therapy. Anabolic hormones. Systemic glucocorticoids. Cytokine inhibitors. Oral contraceptives. Cytokines. Ketoconazole. Any other medication that might interfere with the objectives of this study. AS PER AMENDMENT 9/26/97:DHEA. Patients with the following prior conditions will be excluded: Acute systemic opportunistic infections within 30 days prior to entry. Weight gain >= 3% as documented by self reporting or clinical records during the preceding 4 weeks. AS PER AMENDMENT 9/26/97: Enrollment of such patients should be deferred until weight stabilizes. History of hypersensitivity reaction to megestrol acetate or testosterone enanthate. History of cardiomyopathy or congestive heart failure. Female patients: History of invasive cervical cancer. AS PER AMENDMENT 9/26/97: History of thromboemboli. Prior Medication: Excluded: No testosterone treatment within the previous 8 weeks. Excluded within 30 days prior to entry: Ketoconazole. Initiation or change in antiretroviral therapy. Interleukins. Interferon, anabolic, hormonal or experimental therapies designed to improve appetite or weight gain (e.g., thalidomide, dronabinol, megestrol acetate, cyproheptadine, anabolic steroids, systemic glucocorticoids, pentoxifylline, or growth hormone). AS PER AMENDMENT 9/26/97: Dehydroepiandrosterone (DHEA).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Schambelan M
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mulligan K
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Von Roenn JH
Official's Role
Study Chair
Facility Information:
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Howard University Hosp., Div. of Infectious Diseases, ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Queens Med. Ctr.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Univ. of Hawaii at Manoa, Leahi Hosp.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana Univ. School of Medicine, Wishard Memorial
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Beth Israel Deaconess Med. Ctr., ACTG CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Beth Israel Med. Ctr. (Mt. Sinai)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Cornell University A2201
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke Univ. Med. Ctr. Adult CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Schambelan M, Zackin R, Mulligan K, Sattler FR, Chesney M, Stevens M, Edwards L, Egorin MJ, Von Roenn JH. Effect of testosterone (T) on the response to megesterol acetate (MA) in patients with HIV-associated wasting: a randomized, double-blind placebo-controlled trial (ACTG 313). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 640)
Results Reference
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Learn more about this trial

A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss

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