Completed

HAART Impact on Lean Body Mass in HIV Patients

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What is being collected

Data Collection

Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
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
See protocol details

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

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.

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 enrolled

Total 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 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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

5 inclusion criteria required to participate
Are HIV-positive

Are at least 18 years old

Are enrolled in an adult AIDS clinical trial

Are expected to live at least 6 months

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8 exclusion criteria prevent from participating
Are pregnant or breast-feeding

Are receiving any therapy for a severe infection or medical illness within 14 days prior to study entry

Are receiving any therapy to increase your appetite or gain weight within 30 days prior to study entry

Are taking certain medications

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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 Maps

Univ of California / San Diego Treatment Ctr

San Diego, United States

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, United States

Stanford Univ Med Ctr

Stanford, United States
Completed21 Study Centers