Determination of HIV-1 Production by the Prostate

NCT00001584 | Completed

• 2 other identifiers: 97015897-C-0158
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Pathogenesis; Resistance; Sanctuary Sites; Semen; Sexual Transmission

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related 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. doi: 10.1093/infdis/167.4.798.

  PMID: 8450243 BACKGROUND

• 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. doi: 10.1097/00002030-199612000-00001.

  PMID: 8970677 BACKGROUND

• 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.

  PMID: 2001759 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: July 1, 1997
• Study Completion: April 1, 2001
• Last Updated: March 4, 2008

Record last verified: 2000-05

Locations

US (1)