Effects of Creatine and Resistance Exercise Training in People With HIV Infection
Completed · Phase 2
Conditions studied: HIV Infections
In brief
This study was designed determine whether use of creatine monohydrate, a dietary supplement, can increase skeletal muscle mass and strength and improve the response to progressive resistance exercise training in people with HIV infection.
Key facts
- Study ID
- NCT00484627
- Run by
- National Center for Complementary and Integrative Health (NCCIH)
- People needed
- 43
- Starts
- 2001-08-01
- Expected to finish
- 2003-10-01
- Last updated by the study team
- 2007-06-11
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinically stable, sedentary HIV-positive adults who are on optimized antiretroviral regimens and plan to remain so during the study.
- Men and women on hormone replacement therapy and women using hormonal contraceptives must have been on stable regimens for the preceding 6 months and plan to continue on such treatment throughout the study period.
You may not qualify if…
- Serum creatinine > 1.5 mg/dl or clinical evidence of renal disease or prior kidney transplant
- Creatine kinase (CK) > 1.5 times the upper limit of normal (ULN)
- Hemoglobin < 8.5 g/dl
- AST, ALT, or LDH > 5 X ULN
- Uncontrolled diarrhea (> 6 stools per day)
- Impaired oral intake
- Persistent nausea or vomiting
- Untreated hypogonadism
- Pharmacologic use of growth hormone, testosterone, oxandrolone, nandrolone decanoate, oxymetholone, or other oral, injectable, or transdermal anabolic steroids, androstenedione, or dehydroepiandrosterone (DHEA) within the preceding 6 months (subjects with documented hypogonadism on stable testosterone replacement, defined as a dose < 300 mg q2 weeks for the preceding 6 months, will be allowed to enroll)
- Use of glucocorticoids, megestrol acetate, creatine monohydrate, cytokine inhibitors (thalidomide, pentoxifylline, ketotifen), drugs known to adversely affect renal function, cytokines, parenteral or tube feeding, or initiation of treatment for a systemic infection within 30 days prior to enrollment
- History of angina, coronary heart disease, or congestive heart failure
- Current pregnancy or lactation or plans to become pregnant.
- Because vegetarians are known to have lower intramuscular concentrations of creatine and therefore may experience a much greater relative increase in muscle creatine levels, we will exclude such individuals from this study.
Where it is running
- San Francisco General Hospital — San Francisco, California, United States
Full record on ClinicalTrials.gov
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