CHEMOPROPHYLAXIS FOR THE PREVENTION OF HIV IN ME

Not Applicable

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

• Registration Number: PER-072-06
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS, INSTITUTOS J. DAVID GLADSTONE, FAMILY HEALTH INTERNATIONAL - FHI 360°,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 2339

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.
12) Ability to understand and speak Spanish.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Rapid analysis for HIV: Using the HIV-1/2 Rapid Antibody Test (Abbott Diagnostics) and Bioline HIV-1 / HIV-2 and the Rapid Test (Standard Diagnostics)<br>Confirmatory analysis for HIV: Using a Western Blot model.<br>Measure:Occurrence of infection with HIV.<br>Timepoints:Days 0, 28, 56, 84, 112, 140, 168, 196, 224, 252, 280, 308, 336, 364, 392, 420, 448, 476, 504 and during the follow-up in weeks 4 and 8.<br>