HIV/AIDS
Conditions
Interventions
Dolutegravir
Sponsors
ViiV Healthcare UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must have completed participation in one of the following parent studies, for the duration noted: P1093 parent study through at least Week 180 P2019 parent study through at least Week 48 Virological control at screening: a) Subjects in parent study P1093 must have virological control defined as HIV- 1 RNA <400 c/mL at their penultimate visit (on or after the Week 180 visit). b) Subjects in parent study P2019 must have virological control defined as HIV- 1 RNA <200 c/mL at their penultimate visit (on or after Week 36). Note: If the penultimate P1093 or P2019 visit (on or after Week 180 for P1093; on or after Week 36 for P2019) indicates the possibility of virologic failure, a single retest can be completed in the parent study. – Results of the retest must be obtained and confirmed prior to the Day 1 visit (the Day 1 visit overlaps with the final visit in each parent study). – If the retest indicates virologic control is present as noted above, eligibility is confirmed as long as the participant meets all other entry criteria. – Adherence issues should be addressed, and viral suppression must be confirmed prior to Day 1. Evidence of continued benefit from IP during the subject’s participation in the parent study (P1093 or P2019). – At screening, Investigators will submit a clinical summary verifying evidence of continued benefit from IP during the subject’s participation in the parent study (P1093 or P2019). – The summary will be submitted via the PPD ePIP system to the Study Medical Monitor who will review and confirm if the inclusion criterion has been met. – Confirmation from the Study Medical Monitor is required to meet this eligibility criterion 4. Males and Females All subjects who are engaging in sexual activity should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g. male
Exclusion criteria
Exclusion criteria: Confirmed virologic failure with evidence of resistance to: a) DTG in the P1093 parent study, or b) ABC, DTG or 3TC (with the exception of M184V) in the P2019 parent study 2. Presence of any active Acquired Immunodeficiency Syndrome (AIDS) defining opportunistic infection. 3. Known =Grade 3 laboratory toxicities within 30 days prior to study entry (e.g. neutrophil count, hemoglobin, platelets, aspartate aminotransferase (AST), ALT, lipase, serum creatinine and total bilirubin). Repeat testing is allowed for eligibility determination. NOTE: =Grade 3 total bilirubin is allowable, if the subject is on ATV. NOTE: Subjects with laboratory abnormalities considered unrelated to IP may be allowed to enter the study. Thus, if the laboratory abnormality persists upon repeat testing, the subject may be considered for study entry after consultation and approval of the study team. 4. Previous permanent discontinuation from IP in the parent study due to toxicity, intolerance, or pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study drug will be provided until age-appropriate formulations receive local regulatory approval and are commercially available or are available from some other source (e.g. government programs, aid programs etc) or until the subject no longer derives benefit from treatment or until a subject meets a protocol defined reason for discontinuation or until development of DTG or ABC/DTG/3TC is terminated. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess any serious adverse events (SAEs) and any clinical or laboratory adverse events that lead to the discontinuation of IP (DTG or ABC/DTG/3TC FDC). | — |
Countries
Kenya
Contacts
Public ContactClinical Disclosure Advisor Clinical Disclosure Advisor
Clinical Disclosure Advisor
Outcome results
None listed