The Biology of HIV Transmission

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001092
First received: November 2, 1999
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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

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

Resource links provided by NLM:


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


Estimated Enrollment: 20
Study Start Date: October 1999
Study Completion Date: October 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

HIV-infected adults with recent seroconversion

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001092

Locations
United States, California
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
UCSD
San Diego, California, United States, 92103
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, United States, 94110
Sponsors and Collaborators
Investigators
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

Additional Information:
No publications provided

Responsible Party: Rona Siskind, DAIDS
ClinicalTrials.gov 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: November 1, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Semen
HIV-1
Sexual Partners
Drug Resistance, Microbial
CD8-Positive T-Lymphocytes
Saliva
Blood
Cervix Uteri
Vagina
Acute Infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014