Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study to Monitor Patients With Primary or Early HIV Infection
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000911
  Purpose

The purpose of this study is to monitor patients who recently have been infected with HIV in order to learn how their immune systems respond to HIV infection and to study how the virus acts in their bodies.

Primary HIV infection occurs within 20 days to 8 weeks following exposure to HIV. The symptoms of primary HIV infection are usually fever, tiredness, headache, or muscle aches. However, symptoms vary greatly from person to person, and some people might not experience any symptoms at all. Because these symptoms also resemble the cold or the flu, it is difficult to identify patients with primary HIV infection. Information gathered from this study will help doctors decide what kind of treatment is best to give patients who recently have been infected.


Condition
HIV Infections

MedlinePlus related topics: AIDS
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: An Observational Study of Subjects With Primary HIV Infection: A Study of the UCSD Acute/Early HIV Infection (AEHIV) Clinical Studies Unit

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

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood, lymph node tissue, CSF, and semen or vaginal secretion specimens


Estimated Enrollment: 1500
Study Start Date: October 1999
Estimated Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Primary HIV-1 infection is frequently identified as a nonspecific viral syndrome occurring within 20 days to 8 weeks following a documented HIV exposure. However, symptoms vary from person to person, and some people undergo asymptomatic seroconversion. Because of the difficulty identifying patients with either acute HIV infection (within 30 days of initial infection) or early infection (within 12 months of initial infection), no systematic review of viral dynamics or immunodynamics in this patient population has been undertaken. A better understanding of the virologic and immunologic parameters during acute and early HIV infection should provide information relevant to the optimal design of future clinical therapeutic trials.

The only patient intervention is obtaining blood, lymph node tissue, CSF, and semen or vaginal secretion specimens at designated intervals according to the schedule of evaluations. Patients are followed for 5 years. Patients may elect to start or discontinue antiretroviral therapy at any time; however, no antiretroviral therapy is administered as part of this study. Descriptive analysis includes tolerance and toxicity, magnitude and durability of RNA suppression, magnitude and durability of immunologic responses (CD4 and CD8 cells), and decay and emergence of resistant virus in tissue reservoirs (CSF, genital secretions, and lymph nodes).

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who have recently been infected with HIV

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • Have acute or early HIV infection. The stage of HIV infection will depend on the results of certain lab tests.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000911

Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
Investigators
Principal Investigator: Susan Little
Principal Investigator: Diane Havlir
  More Information

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

Responsible Party: DAIDS ( Rona Siskind )
Study ID Numbers: AIEDRP AI-05-001, SD AEHIV 001, AEHIV 001
Study First Received: November 2, 1999
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00000911  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Semen
HIV-1
Immunity, Cellular
Lymph Nodes
Viremia
Antibodies, Viral
Vagina
Viral Load
Acute Infection

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

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

ClinicalTrials.gov processed this record on January 15, 2009