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A Study to Monitor Patients With Primary or Early HIV Infection

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000911
First received: November 2, 1999
Last updated: November 1, 2012
Last verified: November 2012

November 2, 1999
November 1, 2012
October 1999
June 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000911 on ClinicalTrials.gov Archive Site
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A Study to Monitor Patients With Primary or Early HIV Infection
An Observational Study of Subjects With Primary HIV Infection: A Study of the UCSD Acute/Early HIV Infection (AEHIV) Clinical Studies Unit

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.

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).

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

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

Non-Probability Sample

Patients who have recently been infected with HIV

HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1500
June 2007
June 2007   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000911
AI-05-001, SD AEHIV 001, AEHIV 001, AIEDRP AI-05-001
Not Provided
Rona Siskind, DAIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Susan Little
Principal Investigator: Diane Havlir
National Institute of Allergy and Infectious Diseases (NIAID)
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP