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

NCT00001110 | Completed

• 3 other identifiers: ACTG 723AACTG 72310188
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

HIV Infections

Keywords

Lung; HIV-1; Viremia; Anti-HIV Agents; Viral Load; Bronchoalveolar Lavage Fluid

Interventions

Bronchoalveolar lavage PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 462025250, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 452670405, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Puerto Rico-AIDS CRS

San Juan, 009365067, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections; Viremia

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• HL Twigg

  STUDY CHAIR

• J Wheat

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Start: August 1, 1999
• Study Completion: April 1, 2003
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

US (4); PR (1)