HIV/AIDS
Conditions
Interventions
DTG 3TC
Sponsors
ViiV Healthcare UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in this study only if all the following criteria apply: Investigator confirmation of the participant's continued clinical benefit from the parent study intervention and the participant’s completion of the protocol-defined treatment period in the parent study. The Investigator should ensure that the participant is still eligible for the parent study (i.e., have not met parent study discontinuation/withdrawal criteria). Refer also to Section 4.1.1 of study protocol. Participants or LAR who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable appendix and determined by the Investigator. Participant or LAR is able and willing to provide signed informed consent as described in Section 10.1.3 of study protocol, which includes compliance with the requirements and restrictions listed in the consent form and this protocol. Where applicable, participants must provide written assent. Participants who completed the parent D3 (Penta 21) study and benefited from the study intervention will be eligible to enroll in this continued access study.
Exclusion criteria
Exclusion criteria: Participants are excluded from participating in this study if the following criterion applies: 1. Any reason that, in the opinion of the Investigator or Sponsor, precludes the participant’s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Reasons for discontinuation of study intervention. ;• Incidence and outcome of SAEs. ;Incidence and outcome of AESls (if collected in the applicable study appendix) | — |
Secondary
| Measure | Time frame |
|---|---|
| This is not applicable. | — |
Countries
Uganda
Contacts
Public ContactElizabeth Kaudha
Principle Investigator at Joint Clinical Research
Outcome results
None listed