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.

Condition
HIV Infections

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

California
      UCSD, San Diego,  California,  92103,  United States; Recruiting
      San Francisco Gen Hosp / UCSF AIDS Program, San Francisco,  California,  94110,  United States; Recruiting
      Cedars Sinai Med Ctr, Los Angeles,  California,  90048,  United States; Recruiting

Study chairs or principal investigators

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,  Principal Investigator

Study ID Numbers:  AIEDRP AI-05-007; UCSD Project 98-0776; AEHIV 007
Record last reviewed:  August 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001092
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08