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Determination of HIV-1 Production by the Prostate

Determination of HIV-1 Production by the Prostate

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00001584
Enrollment
35
Registered
2002-12-10
Start date
1997-07-31
Completion date
2001-04-30
Last updated
2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Pathogenesis, Resistance, Sanctuary Sites, Semen, Sexual Transmission

Brief 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 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.

Detailed 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 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.

Interventions

None listed

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026