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HIV InfectionsPhase 2NCT00001079

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

A Phase 2 study testing Testosterone enanthate and Megestrol acetate in people with HIV Infections and HIV Wasting Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, HIV Wasting Syndrome
What is being tested?
Testosterone enanthate and Megestrol acetate
How many people
80 participants
Where
21 sitesUnited States
Study dates
Start not givento Dec 2002
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland, 21287

  • Beth Israel Deaconess Med. Ctr., ACTG CRS

    Boston, Massachusetts, 02215

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Univ. of Cincinnati CRS

    Cincinnati, Ohio

  • Duke Univ. Med. Ctr. Adult CRS

    Durham, North Carolina, 27710

  • Queens Med. Ctr.

    Honolulu, Hawaii, 96813

  • Univ. of Hawaii at Manoa, Leahi Hosp.

    Honolulu, Hawaii, 96816

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic

    Indianapolis, Indiana, 46202

  • Indiana Univ. School of Medicine, Wishard Memorial

    Indianapolis, Indiana, 46202

  • USC CRS

    Los Angeles, California, 90033

  • UCLA CARE Center CRS

    Los Angeles, California, 90035

  • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU

    New Orleans, Louisiana, 70112

  • Beth Israel Med. Ctr. (Mt. Sinai)

    New York, New York, 10003

  • Cornell University A2201

    New York, New York, 10021

  • Memorial Sloan-Kettering Cancer Ctr.

    New York, New York, 10021

  • Hosp. of the Univ. of Pennsylvania CRS

    Philadelphia, Pennsylvania, 19104

  • Ucsf Aids Crs

    San Francisco, California, 94110

  • St. Louis ConnectCare, Infectious Diseases Clinic

    St Louis, Missouri

  • Washington U CRS

    St Louis, Missouri

  • Howard University Hosp., Div. of Infectious Diseases, ACTU

    Washington D.C., District of Columbia, 20060

Other trials in United States

About this study

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.

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.

Read the 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.

Being tested
Testosterone enanthate, Megestrol acetate
Keywords
Placebos, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Wasting Syndrome, Megestrol Acetate, dihydrotestosterone heptanoate
Medical subject headings
HIV Infections, HIV Wasting Syndrome, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Testosterone enanthateDrug

  • Megestrol acetateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionDec 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Intervention model
Parallel groups
Enrolment
80 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001079
Sponsor's protocol ID
ACTG 313
Other IDs
11288
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
1 Nov 2021
Results posted
No

Publications

  • 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)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone enanthate and Megestrol acetate in people with HIV Infections and HIV Wasting Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001079, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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