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The Effects of Anti-HIV Drugs on the HIV Virus in HIV-Infected Patients

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00006442
  Purpose

The purpose of this study is to examine the HIV virus in the blood and lymphoid tissues of patients taking anti-HIV medications.

HIV infection is closely linked to the growth of the HIV virus in the body. Much of this information was obtained from studying how the HIV virus grows in circulating blood. Recent studies have shown that the lymphoid tissue (part of the immune system) is a major site where HIV is found in the body and is also where much of the HIV virus growth occurs. This study will examine not only blood but also lymphoid tissue to gain a better understanding of the disease and how to treat it.


Condition
HIV Infections

MedlinePlus related topics:   AIDS    AIDS Medicines   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Quantitative Assessment of Viral and Lymphocyte Dynamics in Blood and Lymphoreticular Tissues of HIV-1 Infected Patients Treated With Antiretroviral Agents

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   60

Detailed Description:

The natural history and pathogenesis of HIV-1 infection are linked closely to the replication of virus in the body. Studies obtained entirely from analyses of peripheral blood led to a shift in the understanding of HIV-1 pathogenesis. Recent studies have shown that lymphoid tissues are a major reservoir for HIV and the primary site of virus replication. The proposed studies will provide the first comprehensive assessment of HIV-1 expression and lymphocyte response in both blood and lymphocyte tissue compartments. The data obtained will provide new insight into HIV-1 pathogenesis and provide a more rational basis for treatment decisions concerning early therapy of HIV-1 infection.

Patients are admitted to the hospital for insertion of an angiocath to collect blood samples periodically over 48 hours on the day study medication from the parent study is initiated. After discharge, additional blood samples are obtained over a 6-month period. Within 7 days prior to a scheduled biopsy, patients have physical examinations and laboratory evaluations done. All patients undergo some combination of the following during the 2-week prestudy evaluation period and at Weeks 4 and 24: a) superficial lymph node biopsy from cervical, axillary, or inguinal area; b) rectal biopsy; and/or c) tonsillar biopsy. The tissue samples provide an assessment of viral and cellular dynamics.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 18 years old.
  • Are participants in other University of Alabama studies.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are pregnant.
  • Are receiving treatment for an AIDS-defining opportunistic infection, other than preventive treatment.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006442

Locations
United States, Alabama
Michael S. Saag    
      Birmingham, Alabama, United States, 35294

Sponsors and Collaborators
  More Information


Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   AIEDRP AI-08-003, R01 AI35467, UAB/PHA100R
First Received:   November 3, 2000
Last Updated:   July 29, 2008
ClinicalTrials.gov Identifier:   NCT00006442
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Lymphocytes  
HIV-1  
Lymphoid Tissue  
Blood
Anti-HIV Agents
Viral Load

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on October 03, 2008




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