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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000890 |
The purpose of this study is to determine whether HIV-positive patients with extremely low viral loads (level of HIV in the blood) have a greater gain in lean tissue during anti-HIV (antiretroviral) therapy than patients with higher viral loads.
Many HIV-positive patients experience changes in body composition (muscle, fat, etc.) while on antiretroviral therapy. However, any weight gained while taking antiretrovirals is mostly fat. A patient's viral load may affect whether weight gained is a result of increased fat or increased muscle. A large-scale study is needed to closely evaluate the effects of antiretroviral therapy on body composition.
Condition |
HIV Infections |
MedlinePlus related topics: | AIDS AIDS Medicines |
Study Type: | Observational |
Study Design: | Natural History |
Official Title: | Effect of Highly Active Antiretroviral Therapy (HAART) on Lean Body Mass |
Estimated Enrollment: | 200 |
Effective antiretroviral therapy, as measured by a decrease in HIV-1 RNA levels, may sustain or improve important components of body composition, perhaps through a decrease in the underlying pro-inflammatory activity and resting energy expenditure. Moderate weight gain has been reported to be associated with HAART. Meaningful increase in total body weight, however, may need to be comprised of augmentation of lean body mass (primarily muscle), since mortality in HIV and cancer wasting is associated with sizable decreases in lean body mass (LBM) and there is no evidence that increases in fat cell mass are protective. To date, there has not been any large-scale prospective evaluation of the effects of HAART on body composition. Nor has it been determined whether increasing body weight or specific components of body composition (fat or lean body mass) in persons who have lost substantive amounts of weight protects against AIDS-defining complications or prolongs survival.
This is a 48-week, observational study of lean body mass, appetite, functional performance, and systemic markers of inflammation during highly active antiretroviral therapy (HAART) in patients co-enrolled in ACTG antiretroviral studies. Patients are stratified by body mass index (BMI) into 2 cohorts: less than 23 kg/m2 versus greater than or equal to 23 to 28 kg/m2. At selected study visits, times of antiretroviral medication change, and following the diagnosis of an AIDS-defining event, the following are assessed: height (screening visit only), weight, lean body mass, appetite (by questionnaire), functional performance (by questionnaire), and markers of systemic inflammation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |||||
Univ of California / San Diego Treatment Ctr | |||||
San Diego, California, United States, 921036325 | |||||
Stanford at Kaiser / Kaiser Permanente Med Ctr | |||||
San Francisco, California, United States, 94115 | |||||
Stanford Univ Med Ctr | |||||
Stanford, California, United States, 943055107 | |||||
Univ of Southern California / LA County USC Med Ctr | |||||
Los Angeles, California, United States, 900331079 | |||||
United States, District of Columbia | |||||
Howard Univ | |||||
Washington, District of Columbia, United States, 20059 | |||||
United States, Georgia | |||||
Emory Univ | |||||
Atlanta, Georgia, United States, 30308 | |||||
United States, Hawaii | |||||
Queens Med Ctr | |||||
Honolulu, Hawaii, United States, 96816 | |||||
United States, Illinois | |||||
Northwestern Univ Med School | |||||
Chicago, Illinois, United States, 60611 | |||||
Cook County Hosp | |||||
Chicago, Illinois, United States, 60612 | |||||
United States, Louisiana | |||||
Charity Hosp / Tulane Univ Med School | |||||
New Orleans, Louisiana, United States, 70112 | |||||
Tulane Univ School of Medicine | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, Massachusetts | |||||
Beth Israel Deaconess Med Ctr | |||||
Boston, Massachusetts, United States, 02215 | |||||
Beth Israel Deaconess - West Campus | |||||
Boston, Massachusetts, United States, 02215 | |||||
United States, New York | |||||
Cornell Univ Med Ctr | |||||
New York, New York, United States, 10021 | |||||
Beth Israel Med Ctr | |||||
New York, New York, United States, 10003 | |||||
Chelsea Ctr | |||||
New York, New York, United States, 10021 | |||||
United States, Ohio | |||||
Case Western Reserve Univ | |||||
Cleveland, Ohio, United States, 44106 | |||||
Ohio State Univ Hosp Clinic | |||||
Columbus, Ohio, United States, 432101228 | |||||
United States, Pennsylvania | |||||
Univ of Pennsylvania at Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, Washington | |||||
Univ of Washington | |||||
Seattle, Washington, United States, 981224304 | |||||
Puerto Rico | |||||
Univ of Puerto Rico | |||||
San Juan, Puerto Rico, 009365067 |
Study Chair: | C Shikuma | |
Study Chair: | D Mildvan | |
Study Chair: | F Sattler |
Study ID Numbers: | ACTG 892 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000890 |
Health Authority: | United States: Federal Government |
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