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OpenTrials
Completed

NCT Number: NCT00001092

The Biology of HIV Transmission

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars Sinai Med Ctr, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2008
Study completion
2008
First posted
Aug 31, 2001
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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