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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue (Muscle) in HIV-Positive Patients  A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue (Muscle) in HIV-Positive Patients
A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue (Muscle) in HIV-Positive Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are enrolled in an adult AIDS clinical trial. - Are HIV-positive. - Have a viral load of at least 10,000 copies/ml. - Are expected to live at least 6 months. - Are at least 18 years old. Exclusion Criteria Patients will not be eligible for this study if they: - Have a history of diabetes requiring medication. - Have a history of heart disorders. - Have a fever, diarrhea, nausea, or a condition which makes it difficult to eat within the 14 days prior to study entry. - Have swelling due to any cause. - Are pregnant or breast-feeding. - Are receiving any therapy to increase your appetite or gain weight within 30 days prior to study entry. - Are receiving any therapy for a severe infection or medical illness within 14 days prior to study entry. - Are taking certain medications.
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
CShikuma, Study Chair,
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Chelsea Ctr
New York City, New York, 10021
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Additional Information:
Study ID Numbers: ACTG 892;
Study Start Date:
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000890
Other Hiv Infections Studies:
1. A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS
2. Placebo-Controlled Trial of Safety and Efficacy of Thalidomide in Patients With Infections Due to Mycobacterium and/or HIV
3. Treatment Plan to Decrease Drug Exposure in HIV Infected Adolescents
4. A Clinical Trial To Evaluate the Toxicity and Antiviral Effects of a Range of Doses of Ampligen in p24 Antigen Positive HIV-Infected Patients With AIDS or ARC
5. A Phase I Safety and Immunogenicity Study of HIV p17/p24:Ty-VLP in HIV-1 Seronegative Subjects
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A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue (Muscle) in HIV-Positive Patients
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