Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001092
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
1999-11-02
Brief Title:
The Biology of HIV Transmission
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Determinants of the Biology of HIV Transmission to Determine the Immunologic and Virologic Characteristics of Those Who May Have Transmitted HIV to Another Individual
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 look at the amount of HIV in the blood genital fluid and saliva of the partners of patients with early HIV infection This study will also look at the strength of the immune systems of patients with early HIV infection
Because HIV multiplies very quickly in the early stages of infection patients with early HIV infection may be more likely to transmit HIV to their partners The amount of HIV in blood genital fluid and saliva may determine the risk for transmission
Because HIV multiplies very quickly in the early stages of infection patients with early HIV infection may be more likely to transmit HIV to their partners The amount of HIV in blood genital fluid and saliva may determine the risk for transmission
Detailed Description:
Persons with early HIV infection may represent high transmission risk to their partners Early infection characterized by rapid virologic replication insufficient immunologic control of infection and more rapid course of disease progression may be associated with increased infectiousness The viral determinants of transmission may in part be explained by viral burden in blood genital fluids and oral cavity fluids All three fluids may be the source for transmitted virus
Persons with suspected HIV infection are asked to identify their possible source partners The importance of partner referral is emphasized and assisted recruitment or active tracing is offered if necessary Source partners will not be approached uninvited If a partner states that heshe does not want to be contacted then heshe will not be contacted further for the purpose of this study or for any other study All patients are offered HIV counseling and plasma testing for HIV-1 RNA and CD4 cells Blood specimens are collected for plasma determination and cellular and plasma fractions are collected for CAF and neutralization antibodies Neutralization assays are used to detect humoral immune response in patients with primary HIV infection Genital fluids and saliva are analyzed for viral RNA Patients are seen in the clinic on Day 1 for blood draw and return 2 weeks later for blood test results A follow-up period of at least 4 weeks is planned Compensation is provided to all patients
Persons with suspected HIV infection are asked to identify their possible source partners The importance of partner referral is emphasized and assisted recruitment or active tracing is offered if necessary Source partners will not be approached uninvited If a partner states that heshe does not want to be contacted then heshe will not be contacted further for the purpose of this study or for any other study All patients are offered HIV counseling and plasma testing for HIV-1 RNA and CD4 cells Blood specimens are collected for plasma determination and cellular and plasma fractions are collected for CAF and neutralization antibodies Neutralization assays are used to detect humoral immune response in patients with primary HIV infection Genital fluids and saliva are analyzed for viral RNA Patients are seen in the clinic on Day 1 for blood draw and return 2 weeks later for blood test results A follow-up period of at least 4 weeks is planned Compensation is provided to all patients
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 |
|---|---|---|---|
| AIEDRP AI-05-007 | None | None | None |
| UCSD Project 98-0776 | None | None | None |
| AEHIV 007 | None | None | None |