Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000911
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
1999-11-02
Brief Title:
A Study to Monitor Patients With Primary or Early HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Observational Study of Subjects With Primary HIV Infection A Study of the UCSD AcuteEarly HIV Infection AEHIV Clinical Studies Unit
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SD AEHIV 001 | None | None | None |
| AEHIV 001 | None | None | None |
| AIEDRP AI-05-001 | None | None | None |