Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005273
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Pulmonary Complications of HIV Infection Study PACS
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 andor 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 1369 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
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 andor 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 1369 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL048534 | NIH | None | httpsreporternihgovquickSearchU01HL048534 |