Completed

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

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What is being collected

Data Collection

Who is being recruted

HIV Infections

Over 18 Years
How is the trial designed

Natural History

Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.
Observational

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleEffect of Highly Active Antiretroviral Therapy (HAART) on Lean Body Mass 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
200 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Natural History
These studies observe how a disease progresses over time without active treatment. They help researchers understand how conditions typically develop, change, and impact quality of life.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 21 locations
Suspended
Univ of Southern California / LA County USC Med CtrLos Angeles, United StatesSee the location
Suspended
Univ of California / San Diego Treatment CtrSan Diego, United States
Suspended
Stanford at Kaiser / Kaiser Permanente Med CtrSan Francisco, United States
Suspended
Stanford Univ Med CtrStanford, United States

Completed21 Study Centers