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Pulmonary Complications of HIV Infection Study (PACS)

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ClinicalTrials.gov Identifier: NCT00005273
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : March 16, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To evaluate the types, incidence, course, and outcome of pulmonary disorders in newly diagnosed cases of Acquired Immune Deficiency Syndrome (AIDS), newly diagnosed cases of AIDS-related complex (ARC) and newly diagnosed asymptomatic human immunodeficiency virus (HIV) infection.

Condition or disease
Acquired Immunodeficiency Syndrome HIV Infections Lung Diseases Pneumocystis Carinii Infections AIDS-related Complex

Detailed Description:


Pulmonary infections as a group are the most commonly recognized life threatening disorders in patients with the AIDS. Although Pneumocystis carinii was the predominant pulmonary pathogen found in these patients, other organisms were clearly of importance as well, not with early years of the HIV epidemic only in patients with AIDS and ARC but in individuals with asymptomatic HIV infection.

In the mid-1980s, physicians who examined many AIDS patients had the impression that a shift was occurring in the types and incidence of pulmonary complications associated with HIV infection. For example, there appeared to be an increased incidence of serious infections caused by pyogenic bacteria and pulmonary and extrapulmonary infection with M. tuberculosis had been noted with increased frequency. Furthermore, lymphoid interstitial pneumonitis (LIP), which is diagnostic of AIDS in children under 13 years old who are HIV antibody positive, was diagnosed with increased frequency in adults. Nonspecific interstitial pneumonitis also appeared to be on the rise. Legionella pneumonia, in contrast to its increased incidence during 1981-83, was now seldom encountered. However, apart from the increased incidence of tuberculosis, a reportable disease, these other shifts in the incidence of pulmonary complications had not been verified.

Because diagnostic strategies in the development of new treatment regimens and new approaches for clinical research were dependent upon knowledge of the incidence and natural history of pulmonary complications associated with HIV infection, the collection of such information was important.

The Request for Proposals for this initiative was released in January 1987. Awards were made in September 1987. The study was funded jointly by the NHLBI and the NIAID. The study was extended by the cooperative agreement mechanism in FY 1993.


The cohort consisted of 3 groups: Group A HIV seropositive, no symptoms attributable to HIV and CD4+ Cells >= 400 per microliter; Group B HIV seropositive chemical manifestations of HIV in past 6 months or CD4+ Cells < 400 per microliter; and Group C HIV seronegative controls. The pulmonary status of individuals in each of the categories was evaluated by such methods as chest radiography, pulmonary function tests, nuclear medicine studies, and histological and/or microbiological evaluation. The prospective cohort study described the incidence and course of lung diseases at all stages of HIV infection. Six clinical centers from different geographic areas in the United States began enrolling participants in 1988, and the resulting cohort comprised 1,369 members. HIV seropositive participants were randomized to "intensive" (pulmonary disease screening and follow-up at three-month intervals) or "routine" (six-month follow-up intervals with annual screening) follow-up to assess the impact of these strategies on patient outcomes. The contract-supported phase of the study was jointly funded by the NHLBI and the NIAID.

In 1992, the NHLBI decided to extend follow-up for another five years. The contractors applied for research grants which were approved by the National Heart, Lung, and Blood Advisory Council in May 1992 and awarded in October, 1992. In the renewal, particular attention was given to identifying patterns of complications among demographic subgroups that had not been extensively studied, such as women and Blacks, and to defining differences between HIV transmission groups. The study ended in May, 1997.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

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Study Type : Observational
Study Start Date : September 1987
Actual Study Completion Date : May 1997

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005273

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: Jeffrey Glassroth Medical College of Pennsylvania
OverallOfficial: Jeffrey Glassroth Northwestern University
OverallOfficial: Philip Hopewell University of California
OverallOfficial: Paul Kvale Henry Ford Hospital
OverallOfficial: W. Poole RTI International
OverallOfficial: Lee Reichman New Jersey U of Medicine and Dentistry
OverallOfficial: Lee Reichman University of Medicine and Dentistry of New Jersey
OverallOfficial: Mark Rosen Beth Israel Medical Center
OverallOfficial: Mark Rosen Icahn School of Medicine at Mount Sinai
OverallOfficial: Jeanne Wallace University of California

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ClinicalTrials.gov Identifier: NCT00005273    
Other Study ID Numbers: 1300
U01HL048534 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2005
Additional relevant MeSH terms:
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Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Pneumocystis Infections
Lung Diseases
Immunologic Deficiency Syndromes
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immune System Diseases
Slow Virus Diseases
Respiratory Tract Diseases
Bacterial Infections and Mycoses