Completed

Age: 18Years +
All Genders
ID00000890

Effect of Highly Active Antiretroviral Therapy (HAART) on Lean Body Mass

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2005-06-24

200

Participants Needed

21

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 21 locations

1

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States, 900331079

Status Unknown

2

Univ of California / San Diego Treatment Ctr

San Diego, California, United States, 921036325

Status Unknown

3

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, United States, 94115

Status Unknown

4

Stanford Univ Med Ctr

Stanford, California, United States, 943055107

Status Unknown

5

Howard Univ

Washington D.C., District of Columbia, United States, 20059

Status Unknown

6

Emory Univ

Atlanta, Georgia, United States, 30308

Status Unknown

7

Queens Med Ctr

Honolulu, Hawaii, United States, 96816

Status Unknown

8

Northwestern Univ Med School

Chicago, Illinois, United States, 60611

Status Unknown

9

Cook County Hosp

Chicago, Illinois, United States, 60612

Status Unknown

10

Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, United States, 70112

Status Unknown

11

Tulane Univ School of Medicine

New Orleans, Louisiana, United States, 70112

Status Unknown

12

Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States, 02215

Status Unknown

13

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States, 02215

Status Unknown

14

Beth Israel Med Ctr

New York, New York, United States, 10003

Status Unknown

15

Chelsea Ctr

New York, New York, United States, 10021

Status Unknown

16

Cornell Univ Med Ctr

New York, New York, United States, 10021

Status Unknown

17

Case Western Reserve Univ

Cleveland, Ohio, United States, 44106

Status Unknown

18

Ohio State Univ Hosp Clinic

Columbus, Ohio, United States, 432101228

Status Unknown

19

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

20

Univ of Washington

Seattle, Washington, United States, 981224304

Status Unknown

21

Univ of Puerto Rico

San Juan, Puerto Rico, 009365067

Status Unknown

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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