Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of California, San Francisco
First received: February 13, 2009
Last updated: May 19, 2014
Last verified: May 2014
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).
||Observational Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Primary Outcome Measures:
- pulmonary artery pressure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
serum, plasma, PBMCS, BAL
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
HIV-infected individuals with the clinical diagnosis of pulmonary hypertension or HIV-infected individuals who have mildly elevated pulmonary arterial pressures
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
HIV infected individiuals with the clinical diagnosis of pulmonary hypertension or who have mildly elevated pulmonary arterial pressures
- Infection with HIV greater than 6 months in duration
- Right heart catheterization showing PASP > 30mm Hg
- 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.
- Ability to participate in follow-up for the duration of the study.
- Known significant cardiovascular disease, including clinically significant valvular heart disease, congenital heart disease, current or prior symptomatic coronary disease, or known cardiomyopathy.
- Any known pulmonary disease that could potentially cause pulmonary hypertension.
- A pO2 by pulse oximetry below 90% on room air.
- Obstructive sleep apnea.
- Known collagen vascular disease.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845013
|University of California, San Francisco
|San Francisco, California, United States, 94110 |
University of California, San Francisco
No publications provided
||University of California, San Francisco
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 13, 2009
||May 19, 2014
||United States: Institutional Review Board
Keywords provided by University of California, San Francisco:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Acquired Immunodeficiency Syndrome
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Respiratory Tract Diseases
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases