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Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

Study 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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00845013
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of California, San Francisco
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Priscilla Hsue, MD
Principal Investigator Affiliation University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 HIV Infection, Pulmonary Hypertension, Endothelial Function, HIV Infections
Arms & Interventions

Arms

: HIV Infection

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

Interventions

Contact a Trial Team

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University of California, San Francisco, San Francisco, California

Status

Address

University of California, San Francisco

San Francisco, California, 94110

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