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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

November 2, 1999
November 1, 2012
October 1999
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Complete list of historical versions of study NCT00001092 on ClinicalTrials.gov Archive Site
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The Biology of HIV Transmission
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Blood, genital fluids, and saliva collection

Non-Probability Sample

HIV-infected adults with recent seroconversion

HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2008
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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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001092
AI-05-007, UCSD Project 98-0776, AEHIV 007, AIEDRP AI-05-007
Not Provided
Rona Siskind, DAIDS
National Institute of Allergy and Infectious Diseases (NIAID)
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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
National Institute of Allergy and Infectious Diseases (NIAID)
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP