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The Biology of HIV Transmission

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001092
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 22, 2015
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

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 or disease
HIV Infections

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
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
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001092

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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)
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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

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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
AIEDRP AI-05-007
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 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:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases