Determination of HIV-1 Production by the Prostate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-07-31

Study Completion Date

2001-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Pilot Study of the Patterns of Cellular Gene Expression in HIV-1 Patients Following Clinical Events Which Increase Plasma Virus Concentrations

NCT00001681

HIV Infections

COMPLETED

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption

NCT05419024

HIV

RECRUITING PHASE2

The Prevalence of HIV Drug Resistance and Transmission Risk in Opioid Agonist Treatment

NCT00857350

HIV Positive Opioid Dependence Opioid Agonist Treatment +1 more

COMPLETED

Detection of Human Immunodeficiency Virus Type 1 (HIV-1) in Vaginocervical Secretions: Correlation With Clinical Status, Virologic and Immunologic Parameters, and the Presence of Other Infections

NCT00000858

HIV Infections

COMPLETED

Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission

NCT01053741

Human Immunodeficiency Virus (HIV)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

MALE

Accepts Healthy Volunteers

No