Clinical Trials


The Biology of HIV Transmission

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: November 2, 1999
Last updated: October 21, 2015
Last Verified: October 2015
History of Changes


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.

HIV Infections

Study Type: Observational
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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention: Samples With DNA
Blood, genital fluids, and saliva collection

Enrollment: 20
Study Start Date: October 1999
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

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 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 older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  
Sampling Method: Non-Probability Sample  

Study Population

HIV-infected adults with recent seroconversion


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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its 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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)


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
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00001092   History of Changes  
Other Study ID Numbers: AI-05-007  
  UCSD Project 98-0776  
  AEHIV 007  
  AIEDRP AI-05-007  
Study First Received: November 2, 1999  
Last Updated: October 21, 2015  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Sexual Partners
Drug Resistance, Microbial
CD8-Positive T-Lymphocytes
Cervix Uteri
Acute Infection

Additional relevant MeSH terms:
HIV Infections processed this data on February 13, 2020
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