Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00845013
First received: February 13, 2009
Last updated: May 29, 2015
Last verified: May 2015
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Purpose
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).
| Condition |
|---|
|
HIV Infection Pulmonary Hypertension Endothelial Function HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- pulmonary artery pressure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
serum, plasma, PBMCS, BAL
| Estimated Enrollment: | 125 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | June 2019 |
| Estimated Primary Completion Date: | June 2019 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
HIV Infection
HIV-infected individuals with the clinical diagnosis of pulmonary hypertension or HIV-infected individuals who have mildly elevated pulmonary arterial pressures
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV infected individiuals with the clinical diagnosis of pulmonary hypertension or who have mildly elevated pulmonary arterial pressures
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845013
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845013
Locations
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94110 | |
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
More Information
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00845013 History of Changes |
| Other Study ID Numbers: | HIVPAP |
| Study First Received: | February 13, 2009 |
| Last Updated: | May 29, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
HIV infection pulmonary hypertension endothelial function antiretroviral medication Treatment Experienced |
Additional relevant MeSH terms:
|
Infection Communicable Diseases Hypertension HIV Infections Acquired Immunodeficiency Syndrome Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on September 28, 2016