The ongoing study is a phase 3b, noncomparative, randomized, open-label trial in ART-naive adults with HIV-1 and drug-sensitive TB infections.
In a briefing following her presentation of the data in an oral session, Dr. Dooley explained that the reason for the parallel but noncomparative arms in the trial was that it was primarily designed to see how dolutegravir works in HIV/TB coinfected patients. Enrollment of 113 patients from 37 sites in seven countries took about 2 years, and it would have required significantly more time to enroll the more than 500 patients necessary for an adequately powered comparison trial.
The trial was conducted in Argentina, Brazil, Mexico, Peru, Russia, South Africa, and Thailand. Dr. Dooley presented results from a 24-week interim analysis.
Dr. Kelly Dooley
Participants who were on rifampin-based TB therapy for up to 8 weeks were randomized on a 3:2 basis to receive either dolutegravir 50 mg twice daily during and for 2 weeks post-TB therapy, followed by 50 mg once daily (69 patients), or efavirenz 600 mg daily plus two nucleoside reverse transcriptase inhibitors of the investigator’s choice for 52 weeks.