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Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00845013
First received: February 13, 2009
Last updated: May 19, 2014
Last verified: May 2014

February 13, 2009
May 19, 2014
November 2007
June 2014   (final data collection date for primary outcome measure)
pulmonary artery pressure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00845013 on ClinicalTrials.gov Archive Site
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Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension
Not Provided

The purpose of this study is to describe the epidemiology of pulmonary hypertension in individuals with HIV infection and to investigate its pathogenesis. We propose to conduct a prospective observational cohort study to determine the association between highly active antiretroviral therapy (HAART) and viral suppression in HIV-infected patients who have been identified to have pre-clinical pulmonary hypertension (Aim 1). In addition, we will investigate the mechanistic role of the HIV-1 Nef protein and HHV-8 infection in the development and progression of pulmonary hypertension in individuals with HIV (Aim 2). We will also investigate endothelial function in HIV-infected patients with pulmonary hypertension (Aim 3).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

serum, plasma, PBMCS, BAL

Non-Probability Sample

HIV infected individiuals with the clinical diagnosis of pulmonary hypertension or who have mildly elevated pulmonary arterial pressures

  • HIV Infection
  • Pulmonary Hypertension
  • Endothelial Function
  • HIV Infections
Not Provided
HIV Infection
HIV-infected individuals with the clinical diagnosis of pulmonary hypertension or HIV-infected individuals who have mildly elevated pulmonary arterial pressures
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
125
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Infection with HIV greater than 6 months in duration
  2. Right heart catheterization showing PASP > 30mm Hg
  3. Ability to provide reliable history of HIV medications or has received the majority of medical care from San Francisco General Hospital with available records of medical treatment.
  4. Ability to participate in follow-up for the duration of the study.

Exclusion Criteria:

  1. Known significant cardiovascular disease, including clinically significant valvular heart disease, congenital heart disease, current or prior symptomatic coronary disease, or known cardiomyopathy.
  2. Any known pulmonary disease that could potentially cause pulmonary hypertension.
  3. A pO2 by pulse oximetry below 90% on room air.
  4. Obstructive sleep apnea.
  5. Known collagen vascular disease.
  6. History of anorexigen use

    • 7. Age less than 18 years old.
    • 8. Other co-morbidities for which the investigators, in conjunction with the primary care provider, believe render the participant with an expected survival of 6 months or less.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00845013
HIVPAP
No
University of California, San Francisco
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
University of California, San Francisco
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP