Effect of Anti-HIV Therapy (HAART) on HIV Levels in the Lungs and on Lung Cell Inflammation in HIV-Infected Patients

Completed · Not applicable

Conditions studied: HIV Infections

In brief

The purpose of this study is to see: (1) how the amount of HIV in the lungs compares to that in the blood; (2) if HAART reduces the amount of HIV in the lungs; and (3) if HAART reduces lung inflammation in HIV-infected patients. Lung-cell inflammation in HIV-infected patients is probably caused by HIV infection of these cells. The amount of inflammation may correspond to the amount of HIV (viral load) in the lungs (i.e., mild inflammation indicates a low amount of HIV; severe inflammation indicates a high amount of HIV). HAART is used to decrease the amount of HIV in the body. If HAART is able to decrease viral load in the lungs, it should also be able to decrease lung-cell inflammation in these patients.

Key facts

Study ID

NCT00001110

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

50

Starts

1999-08-01

Expected to finish

2003-04-01

Last updated by the study team

2013-07-29

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 HIV-positive.
• Are at least 18 years old.
• Have a CD4 count less than or equal to 500 cells/mm3 and an HIV RNA level greater than or equal to 5000 copies/ml.
• Are about to start a regimen of at least 3 anti-HIV drugs (HAART).

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have ever received protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).
• Have had signs or symptoms of lung disease in the past 30 days (pneumonia, bronchitis, emphysema, asthma, severe cough, or severe shortness of breath).
• Have received certain medications, including HIV vaccines.
• Have received chemotherapy within 30 days prior to study entry, or have cancer that will require chemotherapy.
• Are pregnant and will be beyond the first 3 months of pregnancy by Week 24 (Month 6) of the study.

Where it is running

• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• Puerto Rico-AIDS CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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