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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00001079
• Date of registration: 02/11/1999
• Primary sponsor: National Institute of Allergy and Infectious Disease (NIAID)
• Public title: A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
• Scientific 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.
• Date of first enrolment: June 1996
• Target sample size: 80
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001079
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Mulligan K

• Name: Schambelan M

• Name: Von Roenn JH

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

HIV Wasting Syndrome

Intervention(s)

Drug: Megestrol acetate

Drug: Testosterone enanthate

Secondary ID(s)

11288

ACTG 313

Source(s) of Monetary Support

Please refer to primary and secondary sponsors