A Study to Monitor Patients With Primary or Early HIV Infection

HIV Infections Clinical Trial

Official title:

An Observational Study of Subjects With Primary HIV Infection: A Study of the UCSD Acute/Early HIV Infection (AEHIV) Clinical Studies Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000911
• Other study ID #: AI-05-001
• Secondary ID: SD AEHIV 001AEHI
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: October 21, 2015
• Start date: October 1999
• Est. completion date: June 2007

Study information

• Verified date: October 2015
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

External Links

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