PH3b, DTG Study in HIV-1 Subjects Completing IMPAACT Study P1093
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03016533|
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infection, Human Immunodeficiency Virus||Drug: Dolutegravir film-coated tablets Drug: Dolutegravir film-coated dispersible tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Access to Dolutegravir for HIV-1 Infected Children and Adolescents Completing IMPAACT Study P1093|
|Actual Study Start Date :||June 7, 2017|
|Estimated Primary Completion Date :||December 29, 2023|
|Estimated Study Completion Date :||December 29, 2023|
Experimental: Dolutegravir Continued Access
All participants will receive dolutegravir film-coated tablets or film-coated dispersible tablets at appropriate doses selected as per their age and weight bands. For those participants who were previously receiving dolutegravir in study P1093 (parent study), dolutegravir will be supplied as film-coated tablets containing 10 mg, 25 mg and 50 mg of dolutegravir and 5 mg film-coated dispersible tablets of dolutegravir. Participants will receive dolutegravir until age-appropriate formulations are available to them from some other source, or until participant is no longer deriving benefit from treatment, or participant are discontinued, or until development of dolutegravir is terminated. The dose adjustment will be made if a participant's weight change requires a dose adjustment. Aging participants (those who crosses age-boundaries) who are taking the dispersible tablet formulation will be allowed to switch to the tablet formulation once daily if they are able to swallow the tablet.
Drug: Dolutegravir film-coated tablets
Dolutegravir film-coated tablets will be provided as 10 mg, 25 mg and 50 mg tablets. It will be administered at the dose of approximately 1 mg/kilogram (kg) with maximum dose of 50 mg to participants as per their age and weight band.
Drug: Dolutegravir film-coated dispersible tablets
Dolutegravir film-coated dispersible tablets will be provided as 5 mg dispersible tablets. It will be administered at the appropriate dose as determined by results of the parent protocol to participants as per their age and weight band.
- Continued access to dolutegravir [ Time Frame: Assessed up to average of 2 years ]To provide access to dolutegravir in an open-label protocol to eligible participants who have completed the P1093 study.
- Incidence and severity of serious adverse events (SAEs) as a measure of safety [ Time Frame: Assessed up to average of 2 years ]An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function.
- Number of participants with any clinical or laboratory adverse events leading to discontinuation of dolutegravir [ Time Frame: Assessed up to average of 2 years ]An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016533
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|GSK Investigational Site||Recruiting|
|Chiang Mai, Thailand, 50200|
|Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com|
|Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||ViiV Healthcare|