A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue (Muscle) in HIV-Positive Patients

NCT ID: NCT00000890

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL

Brief Summary

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.

Detailed Description

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.

Conditions

HIV Infections

Study Design

• Observational Model Type: NATURAL_HISTORY

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Principal Investigators

C Shikuma

Role: STUDY_CHAIR

D Mildvan

Role: STUDY_CHAIR

F Sattler

Role: STUDY_CHAIR

Locations

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

Univ of California / San Diego Treatment Ctr

San Diego, California, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, United States

Stanford Univ Med Ctr

Stanford, California, United States

Howard Univ

Washington D.C., District of Columbia, United States

Emory Univ

Atlanta, Georgia, United States

Queens Med Ctr

Honolulu, Hawaii, United States

Northwestern Univ Med School

Chicago, Illinois, United States

Cook County Hosp

Chicago, Illinois, United States

Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, United States

Tulane Univ School of Medicine

New Orleans, Louisiana, United States

Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

Beth Israel Med Ctr

New York, New York, United States

Chelsea Ctr

New York, New York, United States

Cornell Univ Med Ctr

New York, New York, United States

Case Western Reserve Univ

Cleveland, Ohio, United States

Ohio State Univ Hosp Clinic

Columbus, Ohio, United States

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, United States

Univ of Washington

Seattle, Washington, United States

Univ of Puerto Rico

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

Sattler FR, Schroeder ET, Dube MP, Jaque SV, Martinez C, Blanche PJ, Azen S, Krauss RM. Metabolic effects of nandrolone decanoate and resistance training in men with HIV. Am J Physiol Endocrinol Metab. 2002 Dec;283(6):E1214-22. doi: 10.1152/ajpendo.00189.2002. Epub 2002 Aug 27.

Reference Type: BACKGROUND

PMID: 12388173 (View on PubMed)

Shikuma CM, Zackin R, Sattler F, Mildvan D, Nyangweso P, Alston B, Evans S, Mulligan K; AIDS Clinical Trial Group 892 Team. Changes in weight and lean body mass during highly active antiretroviral therapy. Clin Infect Dis. 2004 Oct 15;39(8):1223-30. doi: 10.1086/424665. Epub 2004 Sep 27.

Reference Type: BACKGROUND

PMID: 15486848 (View on PubMed)

Other Identifiers

ACTG 892

Identifier Type: -

Identifier Source: org_study_id