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 tuberculosis infection (LTBI). This trial focuses on people at higher risk of developing active tuberculosis and is conducted in various settings with different TB incidence rates. The study aims to test if the shorter treatment is not worse than the longer standard treatments in terms of safety and effectiveness. Participants are randomly assigned to either the experimental group receiving 600 mg of rifapentine daily for 6 weeks or to a control group receiving one of three standard treatments: 12 weeks of once-weekly rifapentine and isoniazid, 12 weeks of daily rifampin and isoniazid, or 16 weeks of daily rifampin. Dosage adjustments are made based on patient weight according to established guidelines. A total of 1,120 participants will be assessed for safety and 3,400 for effectiveness, followed for 24 months after enrollment. During the study, participants will be monitored for treatment discontinuation due to adverse drug reactions and for the development of tuberculosis. Safety and effectiveness will be evaluated by comparing the rates of drug discontinuation and new TB cases between the two groups. Follow-up includes clinical assessments and laboratory tests over a 24-month period to ensure comprehensive monitoring of participant health and treatment outcomes.

Researchers are evaluating new drug regimens for treating adults with drug-susceptible pulmonary tuberculosis (TB) in a Phase 2 adaptive, randomized, controlled, open-label trial. The study aims to determine if these novel treatments provide better early effectiveness compared to the standard combination of isoniazid, rifampicin, pyrazinamide, and ethambutol. The safety and tolerability of these regimens will also be assessed over an 8-week treatment period. Participants will receive one of several drug combinations, including standard therapy with isoniazid, rifampicin, pyrazinamide, and ethambutol, or experimental regimens containing drugs like bedaquiline, pretomanid, linezolid, TBI-223, and sutezolid. Dosing varies by drug, with most taken orally once daily, often with meals. The initial 8 weeks constitute the study treatment phase, followed by an 18-week continuation phase of standard care, making the total treatment duration 26 weeks. Throughout the study, participants will undergo regular assessments, including sputum cultures to measure bacterial growth rates during the first 6 weeks and monitoring for any serious side effects by week 8. Laboratory tests, chest x-rays, and performance scores will be used to evaluate health status. Participants will be followed for a total of 52 weeks, ensuring safety and treatment effectiveness are closely monitored.

Researchers are exploring how very early intensive antiretroviral therapy (ART), with or without a broadly neutralizing antibody (bNAb), may help infants living with HIV achieve HIV remission, defined as having HIV RNA levels below the detection limit of the test. This Phase I/II study focuses on infants born to mothers with presumed or confirmed HIV infection and aims to evaluate the impact of starting treatment within 48 hours of birth. The study includes two groups: infants born to mothers who received little or no antiretrovirals during pregnancy, and infants confirmed HIV positive shortly after birth who started ART quickly. The study tests seven different intensive therapy regimens involving combinations of nucleoside reverse transcriptase inhibitors (NRTIs), nevirapine (NVP), lopinavir/ritonavir (LPV/r), raltegravir (RAL), dolutegravir (DTG), and monoclonal antibodies VRC01 or VRC07-523LS. Treatments are given orally or by subcutaneous injection depending on the drug. The study is conducted in four steps: initial enrollment and evaluation within 48 hours of birth (Step 1), up to 192 weeks of ART treatment with monitoring and possible treatment interruption if virus suppression is achieved (Step 2), close monitoring during treatment interruption for up to five years (Step 3), and re-initiation of ART with ongoing monitoring if the virus returns or other criteria are met (Step 4). Participants will be closely monitored throughout the study with regular HIV testing, physical exams, and assessments of immune health. Safety monitoring will continue for infants who do not have confirmed infection but received initial treatment. Children who maintain viral suppression will undergo analytic treatment interruption and be followed for viral rebound. Outcome measures include the number of participants who reach HIV remission by week 48. The study may last up to five years for some participants, including long-term follow-up through re-treatment and viral monitoring.