CHEMOPROPHYLAXIS FOR THE PREVENTION OF HIV IN ME

INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS, INSTITUTOS J. DAVID GLADSTONE, FAMILY HEALTH INTERNATIONAL - FHI 360°,0 sites2,339 target enrollmentMarch 15, 2007

Conditions-Z21 Asymptomatic human immunodeficiency virus [HIV] infection status Asymptomatic human immunodeficiency virus [HIV] infection status Z21

Overview

Phase: 未知
Intervention: Not specified
Conditions: -Z21 Asymptomatic human immunodeficiency virus [HIV] infection status
Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS, INSTITUTOS J. DAVID GLADSTONE, FAMILY HEALTH INTERNATIONAL - FHI 360°,
Enrollment: 2339
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 15, 2007

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS, INSTITUTOS J. DAVID GLADSTONE, FAMILY HEALTH INTERNATIONAL - FHI 360°,

Eligibility Criteria

Inclusion Criteria

•1\) Male sex (at birth).
•2\) Ability and willingness to give written informed consent.
•3\) Age equal to or greater than 18 years.
•4\) No presence of infection with HIV\-1\.
•5\) Evidence of high risk to acquire infection with HIV\-1 including one of the following criteria: (1\) Not having used a condom during the last receptive and / or insertive anal intercourse with a sexual partner infected with HIV or whose knowledge of HIV infection status is unknown. (2\) Have had receptive anal sex with more than 5 sexual partners during the past 6 months. (3\) Have exchanged money, gifts, place to spend the night or drugs in exchange for anal sex during the last 6 months. (4\) Have been diagnosed with an STI in the last 6 months or at the time of screening. (5\) Be a sexual partner of a man infected with HIV, referring to not using condoms consistently.
•6\) Able to provide your address of residence and that of a personal contact.
•7\) Ambulatory performance status ≥ 80 on the Kamofsky scale.
•9\) Adequate renal function evaluated within the first 28 days prior to enrollment.
•10\) Adequate liver function.
•11\) Adequate haematological function.

Exclusion Criteria

•1\) Positive result for glucosuria or proteinuria in the urine dipstick test.
•2\) Active or serious infection previously diagnosed.
•3\) History of pathological fractures not related to trauma.
•4\) Consumption of alcohol or drugs considered sufficient to prevent compliance with any of the study procedures.
•5\) Upon enrollment, if there is any condition that may interfere with the participant s ability to provide informed consent, make their participation in the study unsafe, complicate the interpretation of the results, or otherwise interfere with the ability to reach the results of the study.