Testosterone and Physical Function in HIV+ Men

NCT00260143 | Completed Phase 2 FDA Drug

• 3 other identifiers: DK49296 (completed)CDU IRB#: 00-11-153-04R01DK049296
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).

Conditions

HIV Associate Weight Loss

Keywords

HIV+ men; Treatment Experienced

Outcome Measures

Primary Outcomes (3)

• Stair climb

  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.

  16 weeks

• Walking speed

  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).

  16 weeks

• Load carry

  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.

  16 weeks

Study Arms (2)

Testosterone enanthate

EXPERIMENTAL

300 mg of testosterone enanthate by intramuscular injection once weekly for 16 weeks

Drug: Testosterone enanthate

Placebo

PLACEBO COMPARATOR

Placebo (sesame oil) by intramuscular injection once weekly for 16 weeks

Drug: Placebo

Interventions

Testosterone enanthate DRUG

Testosterone enanthate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Charles Drew University of Medicine and Science: collaborator

Study Sites (1)

Charles R. Drew University

Los Angeles, California, 90059, United States

Location

Related Publications (1)

• Knapp PE, Storer TW, Herbst KL, Singh AB, Dzekov C, Dzekov J, LaValley M, Zhang A, Ulloor J, Bhasin S. Effects of a supraphysiological dose of testosterone on physical function, muscle performance, mood, and fatigue in men with HIV-associated weight loss. Am J Physiol Endocrinol Metab. 2008 Jun;294(6):E1135-43. doi: 10.1152/ajpendo.90213.2008. Epub 2008 Apr 22.

  PMID: 18430965 RESULT

MeSH Terms

Interventions

testosterone enanthate

Study Officials

• Shalender Bhasin, MD

  Charles R. Drew University and Boston University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: May 1, 2003
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

US (1)