The Biology of HIV Transmission
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
|Study Start Date:||October 1999|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001092
|United States, California|
|Cedars Sinai Med Ctr|
|Los Angeles, California, United States, 90048|
|San Diego, California, United States, 92103|
|San Francisco Gen Hosp / UCSF AIDS Program|
|San Francisco, California, United States, 94110|
|Principal Investigator:||James Kahn|
|Principal Investigator:||Margaret Chesney|
|Principal Investigator:||Rick Hecht|
|Principal Investigator:||Susan Little|
|Principal Investigator:||Eric Daar|
|Principal Investigator:||Jay Levy|
|Principal Investigator:||Robert Grant|