Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000890
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study to Evaluate the Effect of Anti-HIV Therapy on Lean Tissue Muscle in HIV-Positive Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Effect of Highly Active Antiretroviral Therapy HAART on Lean Body Mass
Status:
COMPLETED
Status Verified Date:
2002-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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 kgm2 versus greater than or equal to 23 to 28 kgm2 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
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 kgm2 versus greater than or equal to 23 to 28 kgm2 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: