Search / Trial NCT00001584

Determination of HIV-1 Production by the Prostate

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

Trial Information

Current as of December 14, 2024

Completed

Keywords

Pathogenesis Resistance Sanctuary Sites Semen Sexual Transmission

ClinConnect Summary

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.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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