- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00484627
Effects of Creatine and Resistance Exercise Training in People With HIV Infection
Ergogenic Effects of Creatine Supplementation in HIV Infection
Study Overview
Status
Conditions
Detailed Description
This is a randomized, placebo-controlled study to evaluate the effect of creatine monohydrate, a dietary supplement, on skeletal muscle size and function (i.e., strength, energy metabolism, work capacity, fatigue); whole-body exercise performance; and body composition. This study is also designed to determine whether creatine supplementation augments the functional benefit derived from progressive resistance exercise. The safety of creatine supplementation in people with HIV infection will also be evaluated. Forty HIV-positive subjects will be randomly assigned, on a 1:1 basis, to receive creatine monohydrate or placebo for a period of 14 days, followed by a 12-week program of supervised progressive resistance exercise training during which administration of creatine monohydrate or placebo will continue.
Measurements of muscle strength, size, composition, energetics and fatigue, as well as body weight and composition and serum biochemistries, will be made at baseline, after two weeks of treatment with creatine or placebo (before PRT), and again after 12 weeks of PRT (study week 14). Safety will be monitored throughout the study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- San Francisco General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle strength
Time Frame: 14 weeks
|
14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle size
Time Frame: 14 weeks
|
14 weeks
|
Muscle energetics
Time Frame: 14 weeks
|
14 weeks
|
Body composition
Time Frame: 14 weeks
|
14 weeks
|
Biochemistries
Time Frame: 14 weeks
|
14 weeks
|
Safety
Time Frame: Throughout the study
|
Throughout the study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Morris Schambelan, MD, University of California, San Francisco; San Francisco General Hospital
- Study Director: Kathleen Mulligan, PhD, University of California, San Francisco; San Francisco General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- HIV Infections
- Infections
- Communicable Diseases
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- R01AT000491-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Use of creatine monohydrate (a dietary supplement)
-
University of UtahNational Cancer Institute (NCI)RecruitingFatigue | Sedentary Lifestyle | Metastatic Prostate Carcinoma | Stage IV Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVA Prostate Cancer AJCC (American Joint Committee on Cancer) v8 | Stage IVB Prostate Cancer AJCC (American Joint Committee on Cancer) v8United States
-
Massachusetts General HospitalCompletedHuntington's Disease (HD)United States
-
Texas A&M UniversityNutraboltCompletedDietary Supplementation
-
Texas A&M UniversityNutraboltCompletedDietary Modification
-
Dynamical Business and Science Society - DBSS International...CES University; INDEPORTES AntioquiaCompleted
-
The Cleveland ClinicCompletedHypercholesterolemia | Weakness | Cramps | AchesUnited States
-
Perry RenshawCompletedMajor Depressive DisorderUnited States
-
University of Kansas Medical CenterAlzheimer's AssociationRecruiting
-
Psychiatric Research Unit, Region Zealand, DenmarkUniversity of Southern DenmarkNot yet recruitingMild Traumatic Brain Injury | Concussion, Brain
-
University of UtahRecruitingMajor Depressive DisorderUnited States