Testosterone and Physical Function in HIV+ Men
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00260143 |
Recruitment Status :
Completed
First Posted : December 1, 2005
Last Update Posted : March 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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HIV Associate Weight Loss | Drug: Testosterone enanthate Drug: Placebo | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 61 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Testosterone and Physical Function in HIV Associate Weight Loss |
Actual Study Start Date : | May 2003 |
Actual Primary Completion Date : | June 2006 |
Actual Study Completion Date : | June 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Testosterone enanthate
300 mg of testosterone enanthate by intramuscular injection once weekly for 16 weeks
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Drug: Testosterone enanthate |
Placebo Comparator: Placebo
Placebo (sesame oil) by intramuscular injection once weekly for 16 weeks
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Drug: Placebo |
- Stair climb [ Time Frame: 16 weeks ]A modification of the Margaria stair climb was used to assess stair-climbing power. participants were instructed to ascend a 12-step staircase as rapidly as possible, with ascent time recorded over the middle four steps (0.66 m) of the climb.
- Walking speed [ Time Frame: 16 weeks ]Participants were instructed to walk a 160-m flat course as fast as possible without running. Photoelectric cells and timers were used to determine time to the nearest 0.01 s. The faster of two trials was used to calculate walking speed (m/s).
- Load carry [ Time Frame: 16 weeks ]To simulate daily activities such as carrying groceries or suitcases, participants carried a load equal to 20% of their body weight while walking a distance of 20 m as fast as possible on a flat course.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV positive men, 18-60 years of age, with objective evidence of HIV-infection with low to low-normal testosterone levels (<400 ng/dL). In boys before the age of 18, the hormonal and body composition changes of puberty can confound the data. We will exclude men over 60 because of age-related changes in testosterone levels and body composition, and increased risk of prostate disease.
- Documented weight loss within the previous 6 months of between 5-15% of body weight, or an actual body mass index (BMI) at screening of between 17 and 20 (= 85-95% of the lower limit of ideal weight).
- An energy intake of at least 80% of the estimated requirements. On stable and potent antiretroviral therapy for at least 12 weeks, and in whom, in the opinion of the primary care provider, a change in antiretroviral therapy is unlikely in the next 4 months. Stable therapy may include those not on any antiretroviral therapies and whom, in the opinion of the primary care provider, will not be starting antiretroviral therapy in the next 4 months CD4 cell count >50 /mm3, and HIV-copy number less than 10,000 copies/ml Testosterone levels <400ng/dL Able and willing to provide informed consent and comply with the protocol
Exclusion Criteria:
- Concurrent severe lipodystrophy* according to the patient and the investigator, defined as "the new appearance of thin extremities due to loss of subcutaneous fat (especially the medial compartment of the thigh) along with the new appearance of prominent veins. Loss of tissue in the buccal fat pad and subgluteal region provides further evidence that thin extremities may be in large part due to loss of fat and not just muscles."
- History of prostatic or mammary cancer
- Significant diarrhea defined as 6 or more stools per day with recent change in bowel habits towards more frequent stools, especially if associated with weight loss and fever
- Use of any androgen, growth hormone, or other anabolic or orexigenic agents within the past 6 months
- Use of systemic corticosteroids, except for topical application
- Significant cardiac, renal, hepatic or other diseases that, in the opinion of the Investigator, may put the subject at risk if entered onto the trial or prevent successful completion of the trial.
- AIDS defining illness (CDC HIV Classification, 1993: Clinical Category C) within the previous 3 months (except HIV wasting syndrome)
- Malignancy, other than Kaposi's Sarcoma localized to the skin
- Involvement in (vigorous) resistance exercise training programs (body building) in the past 3 months
- Diabetes mellitus Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological defect that would preclude measurements of muscle strength or physical function
- Severe symptoms of BPH (American Urological Association [AUA] symptom index score of >14), prostate nodule or induration on digital rectal examination (DRE) unless there has been a negative transrectal biopsy within 3 months, and prostate specific antigen (PSA) > 4
- Untreated severe obstructive sleep apnea, as assessed by Berlin's symptom score.
- Current alcohol or drug dependence which would interfere with compliance for the study
- Subject receive investigational treatment except stable antiretroviral investigational drug in the last 12 weeks
- Subject have a history of hypersensitivity to anabolic steroids or to growth hormone
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Any of the following blood test results:
- Liver function test (ALT, AST) 5x the upper limit of the normal range (ULN)
- Alkaline Phosphotase > 5x ULN or > 3x ULN if bilirubin is above normal
- Cholesterol total (> 5 x ULN) or triglycerides 700 mg/dL
- Serum Creatinine 2x ULN
- Hemoglobin 8.0 g/dl or >18 g/dL
- Platelet count < 50x109/L
- HCT >48%
- PSA 4 ng/ml.
- Concomitant Medications: Men who have received in the preceding 6 months or are currently using androgenic steroids, rhGH, IGF-I or other anabolic agents or appetite stimulants will be excluded. Also, excluded are drugs that affect testosterone secretion or metabolism such as ketoconazole, dilantin, and phenobarbital. Patients who have been on a stable dose of erythropoietin for at least 3 months will be allowed to continue the drug. The changes in antiretroviral therapy except for changes within the same class of drugs are not allowed. The use of corticosteroids, except for topical application, is not allowed. The food supplements that might affect body composition such as creatine, high dose amino-acid supplements, whey protein supplements, androstenedione, DHEA, and marinol, are also not allowed.
- On the Exclusion of Women. Women are not being included in this study because testosterone administration in these doses will inevitably cause virilization, and is ethically unacceptable.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260143
United States, California | |
Charles R. Drew University | |
Los Angeles, California, United States, 90059 |
Principal Investigator: | Shalender Bhasin, MD | Charles R. Drew University and Boston University Medical Center |
Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00260143 |
Other Study ID Numbers: |
DK49296 (completed) CDU IRB#: 00-11-153-04 ( Other Identifier: Charles R Drew University ) R01DK049296 ( U.S. NIH Grant/Contract ) |
First Posted: | December 1, 2005 Key Record Dates |
Last Update Posted: | March 9, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
HIV+ men Treatment Experienced |
Weight Loss Body Weight Changes Body Weight Methyltestosterone Testosterone Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents |