None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with FTC / TDF of 200/300 mg, co-formulation, PO, QD for 72 weeks.
Group name:GROUP 2 Type of group
This group will be treated with FTC / TDF Placebo, co-formulation, PO, QD for 72 weeks.
Sponsors
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS, INSTITUTOS J. DAVID GLADSTONE, FAMILY HEALTH INTERNATIONAL - FHI 360°,
Eligibility
Inclusion 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. 12) Ability to understand and speak Spanish.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) Confirmatory analysis for HIV: Using a Western Blot model. Measure:Occurrence of infection with HIV. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Laboratory tests: Panels of serum chemistry and hematology, urine test. Evaluation of adverse events through physical examination. Measure:Safety of treatment: 1) Grade 1 or greater of creatinine toxicity. 2) Grade 3 or higher phosphorus toxicity. 3) Grades 2. 3 or 4 of laboratory EAs. 4) Grades 3 or 4 of clinical EAs. 5) Seroconversion to HIV-1. Timepoints:Panels of serum chemistry and hematology: Days 0, 28, 56, 84, 112, 168, 252, 336, 420 and 504 and during the follow-up in weeks 4 and 8. Urine test: Weeks 168, 336 and 504 and during week 8 of follow-up. Physical examination: Days 0, 84, 168, 252, 336, 420 and 504 and in the follow-up during week 8. ; Outcome name:1) Liver profile in blood. 2) Dual Energy X-ray Absorptometry (Dual-Energy X-ray Absorptiometry-DEXA) and physical evaluation of the proportion of fat in the extremities. 3) Analysis of phenotypes and viral genotypes. 4) PCR for HIV-1 RNA levels and flow cytometry for LT-CD4. Measure:1) Number and proportion of participants with reactive results in the presence of HBsAg who experienced reactivation of liver infection during and after chemoprophylaxis with FTC / TDF. 2) Changes in bone mineral density or in the proportion of fat in the extremities in relation to a baseline measurement. 3) Frequency of some evidence of drug resistance within the first 4 weeks after a first reactive analysis for the presence of antibodies against HIV. 4) Levels of Plasma HIV-1 RNA and CD4 + T cell count during the first 24 weeks after a first reagent analysis for the presence of antibodies against HIV. 5) Responses from participants related to risk behavior, adherence and attitudes related to risk of HIV infection and adherence. Timepoints:Liver profile: Days 0, 28, 56, 84, 112, 168, 252, 336, 420 and 504 and during the follow-up in weeks 4 and 8. DEXA: Days 0, 196, 336 and 504. Physical evaluation: Days 0, 84, 168, 252, 336, 420 and 504 and in the fol | — |
Countries
Peru
Outcome results
None listed