HAART Impact on Lean Body Mass in HIV Patients
Data Collection
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Natural History
Observing the progression of a disease in untreated individuals in order to understand its typical course and outcomes.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Natural History
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Univ of Southern California / LA County USC Med Ctr
Los Angeles, United StatesOpen Univ of Southern California / LA County USC Med Ctr in Google MapsUniv of California / San Diego Treatment Ctr
San Diego, United StatesStanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, United StatesStanford Univ Med Ctr
Stanford, United States