Determination of HIV-1 Production by the Prostate

HIV Infections Clinical Trial

Official title:

Determination of HIV-1 Production by the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001584
• Other study ID #: 970158
• Secondary ID: 97-C-0158
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: July 1997
• Est. completion date: April 2001

Study information

• Verified date: May 2000
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hamed KA, Winters MA, Holodniy M, Katzenstein DA, Merigan TC. Detection of human immunodeficiency virus type 1 in semen: effects of disease stage and nucleoside therapy. J Infect Dis. 1993 Apr;167(4):798-802. — View Citation

Liuzzi G, Chirianni A, Clementi M, Bagnarelli P, Valenza A, Cataldo PT, Piazza M. Analysis of HIV-1 load in blood, semen and saliva: evidence for different viral compartments in a cross-sectional and longitudinal study. AIDS. 1996 Dec;10(14):F51-6. — View Citation

Van Voorhis BJ, Martinez A, Mayer K, Anderson DJ. Detection of human immunodeficiency virus type 1 in semen from seropositive men using culture and polymerase chain reaction deoxyribonucleic acid amplification techniques. Fertil Steril. 1991 Mar;55(3):588-94. — View Citation