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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.

Phase 2
18 Years
Not Enrolling
HIV Infections, HIV Wasting Syndrome

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Trial Information

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.

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.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- 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

- Standard maintenance and prophylaxis therapy for opportunistic infections is
permitted provided patients have been on a stable dosage regimen for 2 weeks prior to

- 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.


- This protocol meets federal requirements governing prisoner participation in clinical

Prior Medication:


- 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:


- Systemic chemotherapy for B-cell lymphoma or malignancies other than Kaposi's
sarcoma. (Patients with Kaposi's sarcoma receiving systemic chemotherapy will not be

- 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.


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:


- 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).

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

Schambelan M

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 313



Start Date:

Completion Date:

December 2002

Related Keywords:

  • HIV Infections
  • HIV Wasting Syndrome
  • Placebos
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • HIV Wasting Syndrome
  • Megestrol Acetate
  • dihydrotestosterone heptanoate
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Wasting Syndrome
  • HIV Wasting Syndrome



UCLA CARE Center CRS Los Angeles, California  90095
USC CRS Los Angeles, California  90033
Ucsf Aids Crs San Francisco, California  
University of Colorado Hospital CRS Aurora, Colorado  80262
Howard University Hosp., Div. of Infectious Diseases, ACTU Washington, District of Columbia  20059
Univ. of Hawaii at Manoa, Leahi Hosp. Honolulu, Hawaii  96816
Northwestern University CRS Chicago, Illinois  60611
Indiana Univ. School of Medicine, Infectious Disease Research Clinic Indianapolis, Indiana  46202
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU New Orleans, Louisiana  70112
Johns Hopkins Adult AIDS CRS Baltimore, Maryland  21287
Beth Israel Deaconess Med. Ctr., ACTG CRS Boston, Massachusetts  02215
St. Louis ConnectCare, Infectious Diseases Clinic St Louis, Missouri  63112
Washington U CRS St. Louis, Missouri  
Memorial Sloan-Kettering Cancer Ctr. New York, New York  10021
Cornell University A2201 New York, New York  10021
Beth Israel Med. Ctr. (Mt. Sinai) New York, New York  10003
Duke Univ. Med. Ctr. Adult CRS Durham, North Carolina  27710
Univ. of Cincinnati CRS Cincinnati, Ohio  45267
Hosp. of the Univ. of Pennsylvania CRS Philadelphia, Pennsylvania  19104
Queens Med. Ctr. Honolulu, Hawaii  96816
Indiana Univ. School of Medicine, Wishard Memorial Indianapolis, Indiana  46202