HIV Infections Clinical Trial
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.
BACKGROUND:
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.
DESIGN NARRATIVE:
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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