Port Au Prince

Researchers are evaluating the safety and effectiveness of a new short 6-week daily rifapentine treatment compared to the standard 12-16 week rifamycin-based treatments for latent Mycobacterium tuberculosis infection LTBI. This trial focuses on people at higher risk of developing active tuberculosis TB and is conducted in locations with varying TB rates where LTBI treatment is routinely provided. The study aims to determine if the shorter treatment is not less safe or effective than the longer standard treatments. Participants are randomly assigned to one of two treatment groups the experimental group receives 600 mg of rifapentine daily for 6 weeks, while the control group receives one of three standard regimens lasting 12 to 16 weeks, including combinations of rifapentine, isoniazid, and rifampin. Dose adjustments are made based on patient weight following established guidelines. Treatments are given according to random assignment and participants are followed for 24 months to assess outcomes. During the study, researchers monitor treatment completion rates, adverse drug reactions, and new cases of active tuberculosis. Safety assessments include tracking serious side effects and drug discontinuation rates. Effectiveness is measured by the occurrence of culture-confirmed or clinical TB within 24 months of enrollment. The study involves regular evaluations and follow-up visits over two years to collect data on treatment tolerability, safety, and TB prevention outcomes.

Researchers are evaluating new drug combinations for treating adults with drug-susceptible pulmonary tuberculosis TB in this Phase 2 randomized trial. The study aims to compare the early effectiveness and safety of these novel regimens against the current standard treatment, which includes isoniazid, rifampicin, pyrazinamide, and ethambutol. The main goal is to see if these new treatments improve early bacterial clearance and maintain acceptable safety over an 8-week period. Participants will be assigned to receive one of several drug regimens during the first 8 weeks. These include the standard treatment or experimental combinations containing bedaquiline, pretomanid, linezolid, TBI-223, or sutezolid at various doses. After the initial 8 weeks, all participants continue with standard therapy for an additional 18 weeks. Medication is taken orally daily, with dosing adjusted by weight and specific guidelines. During the 52-week study, which covers the full treatment and follow-up period, participants will have regular assessments including sputum tests to measure bacterial growth, blood tests to monitor safety, and clinical evaluations. The main outcomes measured are changes in bacterial growth over the first 6 weeks and the occurrence of significant side effects by week 8. Additional measurements include culture conversion rates, adverse events up to week 26, and overall cure rates at 52 weeks. Participants will be closely monitored throughout for safety and treatment response.

Researchers are exploring the effects of early intensive antiretroviral therapy ART, with or without broadly neutralizing antibodies bNAbs, on achieving HIV remission in infants living with HIV. The study includes two groups infants born to mothers with presumed or confirmed HIV infection who received little or no antiretrovirals during pregnancy, and infants diagnosed with HIV within 48 hours of birth who start ART early. This study is a Phase III proof of concept trial aiming to evaluate treatment strategies that may reduce HIV RNA to undetectable levels in infants. The trial assesses seven different intensive therapy regimens combining two nucleoside reverse transcriptase inhibitors NRTIs with other drugs such as nevirapine NVP, lopinavirritonavir LPVr, raltegravir RAL, dolutegravir DTG, and monoclonal antibodies like VRC01 and VRC07-523LS. Participants receive these regimens based on their cohort and specific treatment plan. The study is conducted in four steps initial evaluation and treatment initiation within 48 hours of birth, ongoing treatment for up to 192 weeks with assessments for viral suppression, possible analytic treatment interruption with close monitoring for viral rebound, and re-initiation of ART with monitoring until five years of age or six months after viral suppression. Participants are closely monitored throughout the study with HIV testing, safety assessments, and adherence evaluations. Researchers measure outcomes such as the number of participants achieving HIV remission by Week 48, viral suppression rates, eligibility and response to treatment interruption, and adverse events related to the study treatments. Safety monitoring continues during treatment interruption and after re-treatment. The total participation duration can extend up to five years to assess long-term effects and viral control.