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HIV-Associated Heart Disease Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on HIV-Associated Heart Disease conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. HIV-Associated Heart Disease Clinical research trials and HIV-Associated Heart Disease health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including HIV-Associated Heart Disease. HIV-Associated Heart Disease Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a HIV-Associated Heart Disease clinical trial. Participants oftentimes recieve the most expert healthcare available for their HIV-Associated Heart Disease condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > HIV-Associated Heart Disease  HIV-Associated Heart Disease
HIV-Associated Heart Disease
For Condition: Myocardial Diseases,Heart Diseases,Acquired Immunodeficiency Syndrome,HIV Infections,Cardiovascular Diseases
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To develop natural history data regarding the incidence, clinical course, prognosis, and effects of treatment with anti-viral and immunosuppressive agents on HIV-associated heart disease. A second part of the study evaluated a number of possible mechanisms underlying the development of HIV heart disease.
Details: BACKGROUND: As AIDS reached epidemic proportions it became apparent that heart disease contributed to morbidity in this disease. By 1988, survival following diagnosis with AIDS had improved, and the impact of heart disease on quality of life and survival in these patients had increased in parallel. The spectrum of pathology which comprised AIDS heart disease was diverse and the contribution of cardiac disease to mortality was quite unclear. Unanswered questions included: which seropositive individuals would develop heart disease; what was the spectrum of heart disease in these patients; were there any useful parameters for risk stratification; what was the clinical course; was the etiology due to HIV or other infectious agents or immunologic; did anti-viral agents or immunosuppressive treatment affect the disease course? This project was part of an Institute-initiated study on AIDS-Associated Heart Disease in Adults. The concept was approved by the National Heart, Lung, and Blood Advisory Council in September 1987. The Request for Applications was also released in September 1987. Awards were made in July 1988. DESIGN NARRATIVE: Asymptomatic patients were recruited from the azidothymidine (AZT) versus placebo trial, open label AZT trial, isoprinosine versus placebo trial, and Ampligen versus placebo trial at George Washington University Medical Center. Symptomatic patients were referred from nearby clinics. Baseline information collected included age, sex, weight, HIV risk factors, dates of seroconversion, total CD4 lymphocyte count, clinical symptoms, symptoms of AIDS-related complex, first opportunistic infection, development of tumors or neurologic symptoms, anti-viral therapy, chest pain, symptoms of and treatment for congestive heart failure, evidence of arrhythmia, and initiation of anti-arrhythmic therapy. Date and cause of death were recorded along with autopsy findings. Non-invasive serial electrocardiograms and echocardiograms were performed in all participants at baseline and every four months. Endomyocardial biopsy was performed in patients with congestive cardiomyopathy, those with echocardiographic evidence of left ventricular dysfunction or large pericardial effusions, and those with significant arrhythmias. Endomyocardial biopsies were obtained from ten asymptomatic individuals, five of whom had lymphadenopathy, and five of whom had no lymphadenopathy. Percutaneous pericardiocentesis was performed in patients with large pericardial effusions to obtain samples for bacterial, mycobacterial, HIV and cytomegalovirus cultures. The fact that the majority of these patients were participating in clinical trials of various anti-viral agents allowed evaluation of their effects on the development of heart disease. The second part of the project was a study of the pathogenesis of HIV-associated heart disease. Light and electron microscopic findings were examined in the heart at various clinical stages of HIV infection. Cardiocytes were examined for presence of HIV and other infectious agents.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 1109;
Study Start Date: July 1988
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005229
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