Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment

Launched by JOHNS HOPKINS UNIVERSITY · Jul 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who have both HIV and tuberculosis (TB) and have not yet received any HIV treatment. The trial is comparing two different ways of taking a combination of two medications, dolutegravir and lamivudine, against the standard treatment that includes dolutegravir and two other medications. The goal is to see which method is safer and more effective for managing both infections while participants are also receiving TB treatment.

To be eligible for this trial, participants need to have a confirmed HIV-1 infection with certain levels of virus in their blood and a specific count of immune cells called CD4+. They must also have a diagnosis of pulmonary TB and have never taken HIV medications before. The trial is open to people aged 54 to 78 and 36 to 159, regardless of gender. While the trial is not yet recruiting, participants can expect close monitoring and support throughout the study as researchers gather important information about these treatment options. It’s important to note that pregnant individuals or those planning to become pregnant cannot participate in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Documentation of HIV-1 status: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV 1 RNA viral load. Two or more HIV-1 RNA viral loads of \>1,000 copies/mL are also acceptable as documentation of HIV-1 infection.
• • CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry
• • HIV-1 viral load ≥1000 copies/mL
• • ART-naïve.
• • Documentation of pulmonary TB
• Exclusion Criteria:
• • Pregnant, or plans to become pregnant.