Determination of HIV-1 Production by the Prostate
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Purpose
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.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Official Title: | Determination of HIV-1 Production by the Prostate |
| Estimated Enrollment: | 35 |
| Study Start Date: | July 1997 |
| Estimated Study Completion Date: | April 2001 |
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00001584 History of Changes |
| Other Study ID Numbers: | 970158, 97-C-0158 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Pathogenesis Resistance Sanctuary Sites Semen Sexual Transmission |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013