A Study to Monitor Patients With Primary or Early HIV Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 13 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 1999 |
| End Date: | June 2007 |
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.
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).
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).
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.
We found this trial at
1
site
Click here to add this to my saved trials
