Search / Trial NCT00001584

Determination of HIV-1 Production by the Prostate

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Pathogenesis Resistance Sanctuary Sites Semen Sexual Transmission

Description

Virus present in semen likely contributes substantially to the sexual transmission of HIV. However, the source of HIV in semen is unknown. Some evidence suggests that the prostate may be the source of at least some of the virus in semen. This study is designed to determine whether the prostate may serve as the source of virus in semen by comparing the concentration of HIV-1 RNA in semen donated normally, in semen obtained following prostatic massage, and in expressed prostatic secretions. Finding a source for semen HIV would provide important insights into several aspects of HIV sexual tran...

Gender

Male

Eligibility criteria

  • HIV positive male.
  • Willing and able to participate on study.
  • Age greater than or equal to 18 years.
  • Stable antiretroviral therapy for the preceding 4 weeks and judged likely to remain on stable therapy for the study.
  • Patients with a history of vasectomy or orchiectomy may be admitted to the study, but the data obtained from those patients will be analyzed separately on a pilot basis.
  • Able to provide informed consent.
  • Clinically stable.
  • No clinical or laboratory evidence of bacterial prostatitis.
  • No clinical or laboratory evidence of genito-urinary tract infection.
  • No history of prostatectomy.
  • Absolute neutrophil count greater than 500/ul.
  • Platelets greater than 50,000.
  • Patient must not have had treatment within the prior 8 weeks with anti-androgens or estrogens. Stable therapy with anabolic steroids will be allowed.
  • Patient must not have localized or systemic disease which would, in the opinion of the investigator(s), render the patient at risk following prostatic massage and/or the donation of semen.

Attachments

readout_NCT00001584_2024-03-05.pdf

4.5 MB

NCT00001584_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
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3 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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