Phase 2 HIV and AIDS Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been confirmed to have HIV-1 infection at the screening stage
• People who are either new to HIV treatment (never been treated before) or who are already on a stable HIV medication combination and have had very low levels of virus in their blood (fewer than 50 copies/mL) for at least 3 months
• People whose body weight is more than 3 kg and less than 45 kg
• Females who are not pregnant or breastfeeding, and who are either not able to become pregnant, or who are using an acceptable form of contraception or are not sexually active
• Females who could become pregnant must have a negative pregnancy test within 24 hours before taking the first dose of the study medication

For the study extension phase, additional criteria apply:

• People who have completed the Week 96 visit in the trial
• People whose doctor believes they have benefited from the study treatment by Week 96
• People whose doctor considers them a suitable candidate to continue on the study medication
• People who understand what the extension involves and have given written consent to continue (or whose legal representative has done so, if applicable)

Who may not be able to join:

• People who have signs of kidney disease
• People who have signs of liver disease
• People who have signs or test results suggesting pancreas problems
• People who have any history of cancer
• People who currently have an active AIDS-related opportunistic infection
• People who have an active hepatitis diagnosis, including hepatitis B alongside their HIV
• People who currently have active tuberculosis or are being treated with a medication regimen that includes rifampicin
• People who have a medical condition that prevents them from swallowing or absorbing oral pellets or granules
• People who have any health condition, treatment, or abnormal test result that could affect the study results or prevent full participation
• People who are currently taking, or expected to need, medications that suppress or modify the immune system, or other prohibited treatments
• People who are currently in, or have recently been in, another clinical trial involving an experimental drug or device within the 45 days before the study start
• People whose virus has been shown to be resistant to the study drug doravirine (DOR)
• People who have had a documented episode of high virus levels in their blood (more than 1,000 copies/mL) after being on a specific type of HIV medication (called an NNRTI-based regimen) for at least 3 months

Important: Always verify eligibility with the trial site directly before applying.