Back to resultsDetermination of HIV-1 Production by the Prostate
Primary Purpose
HIV Infections
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for HIV Infections focused on measuring Pathogenesis, Resistance, Sanctuary Sites, Semen, Sexual Transmission
Eligibility 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.
Sites / Locations
- National Cancer Institute (NCI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001584
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00001584
Brief Title
Determination of HIV-1 Production by the Prostate
Official Title
Determination of HIV-1 Production by the Prostate
Study Type
Observational
2. Study Status
Record Verification Date
May 2000
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Pathogenesis, Resistance, Sanctuary Sites, Semen, Sexual Transmission
7. Study Design
Enrollment
35 (false)
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8450243
Citation
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.
Results Reference
background
PubMed Identifier
8970677
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. doi: 10.1097/00002030-199612000-00001.
Results Reference
background
PubMed Identifier
2001759
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.
Results Reference
background
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Determination of HIV-1 Production by the Prostate
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