HIV InfectionsPhase 4NCT00009555
Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat
A Phase 4 study testing Testosterone in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 27 sites in 2 countries.
Trial summary
The purpose of this study is to see if treatment with testosterone will reduce abdominal fat in HIV-positive men. Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have shown that treatment with testosterone may decrease abdominal fat. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Testosterone
- How many people
- 86 participants
- Where
- 27 sitesin 2 countries
- Study dates
- Start not givento Mar 2006
- Phase
- Phase 4
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have been taking anti-HIV medications for at least 12 weeks before study entry and plan to continue taking them for an additional 24 weeks.
- Are male and between 18 and 70 years old.
- Have a measurement of greater than 100 cm around the abdomen.
- Can report an increase in abdominal size after taking antiretroviral drugs.
- Have a viral load less than 10,000 copies/ml within 6 weeks prior to screening.
- Have a serum total testosterone between 125 and 400 ng/dl. If serum total testosterone is greater than 400 ng/dl, bioavailable testosterone must be less than 115 ng/dl or free testosterone must be less than 50 pg/ml.
Who cannot join
- Patients will not be eligible for this study if they:
- Take certain drugs, including testosterone derivatives, glucocorticoids, appetite stimulants, dronabinol, megestrol acetate, androstenediols, oxandrolone, or other anabolic agents such as dehydroepiandrosterone (DHEA) or growth hormone within 12 weeks prior to study entry.
- Take hydroxyurea within 30 days of study entry.
- Take drugs for diabetes.
- Have diabetes.
- Take granulocyte-macrophage colony-stimulating factor (GM-CSF). (Granulocyte colony-stimulating factor (G-CSF) is allowed.)
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- Take cytokines, cytokine inhibitors, or ketoconazole.
- Take ritonavir with simvastatin or lovastatin.
- Have an active opportunistic infection. Patients on treatment for at least 12 weeks will be allowed.
- Have 5-7 loose stools per day or diarrhea for more than 1 week, within 6 weeks of study entry.
- Have a blood pressure greater than 160 over 100.
- Have certain heart problems.
- Have a breast mass that has not been diagnosed.
- Have active cancer.
- Have had prostate cancer or certain other prostate problems.
- Are allergic to any part of the testosterone gel.
- Have a history of blood clots.
- Have a history of sleep apnea.
- Are receiving experimental treatment.
- Are receiving experimental drugs in other studies and do not know if they are taking the drug or placebo.
- Abuse drugs or alcohol in a way that would interfere with the study.
- Are dieting or doing heavy exercising.
- Have a viral load of 10,000 copies/ml or more at screening
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States26 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80262
IHV Baltimore Treatment CRS
Baltimore, Maryland, 21201
Northwestern University CRS
Chicago, Illinois, 60611
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
Univ. of Cincinnati CRS
Cincinnati, Ohio, 452670405
Queens Med. Ctr.
Honolulu, Hawaii, 96816
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 46202
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202
USC CRS
Los Angeles, California, 900331079
Charles R. Drew Univ. of Medicine and Science, Div. of Infectious Diseases
Los Angeles, California, 90059
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455-0392
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska
Stanford CRS
Palo Alto, California, 943055107
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
Philadelphia, Pennsylvania
Pitt CRS
Pittsburgh, Pennsylvania, 15213
Ucsd, Avrc Crs
San Diego, California, 92103
Ucsf Aids Crs
San Francisco, California, 94110
Santa Clara Valley Med. Ctr.
San Jose, California
San Mateo County AIDS Program
San Mateo, California
Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
San Rafael, California
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63108
Washington U CRS
St Louis, Missouri, 63108
About this study
Official title: A Prospective, Multicenter, Randomized, Placebo-Controlled Trial of Physiologic Testosterone Supplementation for HIV-Positive Men With Mildly to Moderately Reduced Serum Testosterone Levels and Abdominal Obesity
The purpose of this study is to see if treatment with testosterone will reduce abdominal fat in HIV-positive men.
Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have shown that treatment with testosterone may decrease abdominal fat. This study will determine if testosterone will reduce abdominal fat in HIV patients.
Read the detailed description
Reports suggest that many HIV-infected patients on antiretroviral therapy experience an increase in abdominal fat. The mechanisms of abdominal fat accumulation in HIV-infected patients are not known. Studies have shown: treatment with testosterone gel reduces total body fat in young, androgen-deficient men; testosterone replacement in middle-aged men with mid-segment obesity decreases visceral fat; and replacement doses of testosterone decrease fat mass and augment lean body mass in HIV-infected men with androgen deficiency. Therefore, there is a strong rationale for evaluating the effectiveness of testosterone replacement in HIV-infected men with visceral obesity and low testosterone levels.
Patients are stratified based on their viral load. Patients receive either testosterone gel or placebo applied to the skin once daily for 24 weeks. Patients remain on their current antiretroviral regimens, which are not supplied through the study. Patients who receive testosterone during the first 24 weeks are eligible to receive it for an additional 24 weeks. Patients on placebo are followed for an additional 24 weeks. Clinical and laboratory evaluations for visceral fat changes are performed throughout the study.
- Conditions
- HIV Infections
- Being tested
- Testosterone
- Keywords
- Testosterone, Anthropometry, Obesity, Abdomen
- Medical subject headings
- HIV Infections, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
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 completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 86 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shalender Bhasin, Study chairCecilia Shikuma, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009555
- Sponsor's protocol ID
- A5079
- Other IDs
- 10175, ACTG A5079, AACTG A5079
- Status last verified
- Oct 2021
- First submitted
- 1 Feb 2001
- Last updated
- 1 Nov 2021
- Results posted
- No
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
- A Prospective, Multicenter, Randomized, Placebo-Controlled Trial of Physiologic Testosterone Supplementation for HIV-Positive Men With Mildly to Moderately Reduced Serum Testosterone Levels and Abdominal Obesity
- ClinicalTrials.gov ID
- NCT00009555
- Acronym / sponsor ID
- A5079
- Conditions
- HIV Infections
- Keywords
- Testosterone, Anthropometry, Obesity, Abdomen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Mar 2006 (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.
The purpose of this study is to see if treatment with testosterone will reduce abdominal fat in HIV-positive men.
Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have shown that treatment with testosterone may decrease abdominal fat. This study will determine if testosterone will reduce abdominal fat in HIV patients.
Detailed description
Reports suggest that many HIV-infected patients on antiretroviral therapy experience an increase in abdominal fat. The mechanisms of abdominal fat accumulation in HIV-infected patients are not known. Studies have shown: treatment with testosterone gel reduces total body fat in young, androgen-deficient men; testosterone replacement in middle-aged men with mid-segment obesity decreases visceral fat; and replacement doses of testosterone decrease fat mass and augment lean body mass in HIV-infected men with androgen deficiency. Therefore, there is a strong rationale for evaluating the effectiveness of testosterone replacement in HIV-infected men with visceral obesity and low testosterone levels.
Patients are stratified based on their viral load. Patients receive either testosterone gel or placebo applied to the skin once daily for 24 weeks. Patients remain on their current antiretroviral regimens, which are not supplied through the study. Patients who receive testosterone during the first 24 weeks are eligible to receive it for an additional 24 weeks. Patients on placebo are followed for an additional 24 weeks. Clinical and laboratory evaluations for visceral fat changes are performed throughout the study.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are HIV-positive.
- Have been taking anti-HIV medications for at least 12 weeks before study entry and plan to continue taking them for an additional 24 weeks.
- Are male and between 18 and 70 years old.
- Have a measurement of greater than 100 cm around the abdomen.
- Can report an increase in abdominal size after taking antiretroviral drugs.
Key exclusion criteria (23 listed)
- Take certain drugs, including testosterone derivatives, glucocorticoids, appetite stimulants, dronabinol, megestrol acetate, androstenediols, oxandrolone, or other anabolic agents such as dehydroepiandrosterone (DHEA) or growth hormone within 12 weeks prior to study entry.
- Take hydroxyurea within 30 days of study entry.
- Take drugs for diabetes.
- Have diabetes.
- Take granulocyte-macrophage colony-stimulating factor (GM-CSF). (Granulocyte colony-stimulating factor (G-CSF) is allowed.)
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 | 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.
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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.
Shalender Bhasin study chair
Cecilia Shikuma study chair
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 27 sites in 2 countries.
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 8 inclusion and 23 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 27 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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.