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Determination of HIV-1 Production by the Prostate

Not Enrolling
HIV Infections

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Trial Information

Determination of HIV-1 Production by the Prostate

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 transmission. Since some
drugs do not enter the prostate well, the finding that virus is produced in the prostate
might suggest the prostate could serve as a reservoir for HIV, leading to the development of
resistance to antiviral agents.

Inclusion 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.

Type of Study:


Study Design:



United States: Federal Government

Study ID:




Start Date:

July 1997

Completion Date:

April 2001

Related Keywords:

  • HIV Infections
  • Pathogenesis
  • Resistance
  • Sanctuary Sites
  • Semen
  • Sexual Transmission
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



National Cancer Institute (NCI) Bethesda, Maryland  20892