NCT00484627

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Aug 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2007

Completed
Last Updated

June 11, 2007

Status Verified

June 1, 2007

First QC Date

June 8, 2007

Last Update Submit

June 8, 2007

Conditions

HIV Infections

Keywords

ExerciseHIVCreatineMuscle

Outcome Measures

Primary Outcomes (1)

  • Muscle strength

    14 weeks

Secondary Outcomes (5)

  • Muscle size

    14 weeks

  • Muscle energetics

    14 weeks

  • Body composition

    14 weeks

  • Biochemistries

    14 weeks

  • Safety

    Throughout the study

Interventions

Use of creatine monohydrate (a dietary supplement)PROCEDURE
Progressive resistance exercise trainingBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • Sakkas GK, Mulligan K, Dasilva M, Doyle JW, Khatami H, Schleich T, Kent-Braun JA, Schambelan M. Creatine fails to augment the benefits from resistance training in patients with HIV infection: a randomized, double-blind, placebo-controlled study. PLoS One. 2009;4(2):e4605. doi: 10.1371/journal.pone.0004605. Epub 2009 Feb 26.

    PMID: 19242554DERIVED

MeSH Terms

Conditions

HIV InfectionsMotor Activity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Study Officials

  • Morris Schambelan, MD

    University of California, San Francisco; San Francisco General Hospital

    PRINCIPAL INVESTIGATOR

  • Kathleen Mulligan, PhD

    University of California, San Francisco; San Francisco General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 8, 2007

First Posted

June 11, 2007

Study Start

August 1, 2001

Study Completion

October 1, 2003

Last Updated

June 11, 2007

Record last verified: 2007-06

Locations

US(1)