Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
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
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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 |
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 2014 |
| Estimated Primary Completion Date: | June 2014 (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 |
| 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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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
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
More Information
No publications provided
| 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 19, 2014 |
| 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:
|
Acquired Immunodeficiency Syndrome HIV Infections Hypertension Hypertension, Pulmonary Infection Cardiovascular Diseases Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections |
Lung Diseases RNA Virus Infections Respiratory Tract Diseases Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Vascular Diseases Virus Diseases |
ClinicalTrials.gov processed this record on February 27, 2015