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.
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
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.
- Conditions
- HIV Infections, HIV Wasting Syndrome
- 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.
- First posted31 Aug 2001 (estimated)
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Schambelan M, Study chairMulligan K, Study chairVon Roenn JH, Study chair
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)
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00001079
- Acronym / sponsor ID
- ACTG 313
- Conditions
- HIV Infections, HIV Wasting Syndrome
- Keywords
- Placebos, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, HIV Wasting Syndrome, Megestrol Acetate, dihydrotestosterone heptanoate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Dec 2002 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.).
Key exclusion criteria (43 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone enanthate | Drug | – |
| Megestrol acetate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- BackgroundSchambelan 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Schambelan M study chair
Mulligan K study chair
Von Roenn JH study chair
21 sites in 1 country: see every site and its status.
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.