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
Data Collection
Collected from today forward - ProspectiveBlood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.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 he/she does not want to be contacted, then he/she 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are at least 18 years old. Have sex with or share injection drugs with a person who is thought to have early HIV infection, or if they have recently become HIV-positive. Can provide written consent. Are available for a follow-up period of at least 4 weeks.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
UCSD
San Diego, United StatesSan Francisco Gen Hosp / UCSF AIDS Program
San Francisco, United States