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

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000890

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

200

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Howard Univ — Washington D.C., District of Columbia, United States
• Emory Univ — Atlanta, Georgia, United States
• Queens Med Ctr — Honolulu, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Charity Hosp / Tulane Univ Med School — New Orleans, Louisiana, United States
• Tulane Univ School of Medicine — New Orleans, Louisiana, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Beth Israel Med Ctr — New York, New York, United States
• Chelsea Ctr — New York, New York, United States
• Cornell Univ Med Ctr — New York, New York, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Univ of Pennsylvania at Philadelphia — Philadelphia, Pennsylvania, United States
• Univ of Washington — Seattle, Washington, United States
• Univ of Puerto Rico — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.