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Completed

NCT Number: NCT00845013

Epidemiology and Pathogenesis of HIV-Associated Pulmonary Hypertension

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).

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Key information

Conditions

HIV Infection Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Endothelial Function Genital Diseases HIV Infections Hypertension Hypertension, Pulmonary Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Pulmonary Hypertension RNA Virus Infections Respiratory Tract Diseases Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. pulmonary artery pressure

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2007
Primary completion
2021
Study completion
2021
First posted
Feb 16, 2009
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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