Approval Probability
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Dolutegravir film-coated · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dolutegravir (DTG) | EXPERIMENTAL | Participants that received DTG film-coated tablets or film-coated dispersible tablets in the parent study P1093, at appropriate doses selected as per their age and weight bands. |
| Abacavir/Dolutegravir/Lamivudine(ABC/DTG/3TC) | EXPERIMENTAL | Participants that received ABC/DTG/3TC immediate release tablets or film-coated dispersible tablets in the parent study P2019, at appropriate doses selected as per their age and weight bands. |
| Name | Type | Description |
|---|---|---|
| Dolutegravir film-coated tablets | DRUG | Dolutegravir film-coated tablets will be provided as 50 mg tablets. |
| Dolutegravir film-coated dispersible tablets | DRUG | 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. |
| ABC/DTG/3TC immediate release tablets | DRUG | ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC. |
| ABC/DTG/3TC film-coated dispersible tablets | DRUG | ABC/DTG/3TC dispersible tablets will be provided as biconvex, oval, film-coated tablets containing 60 mg ABC, 5 mg DTG and 30 mg 3TC. |
Inclusion Criteria: * Participant must have completed participation in one of the following parent studies, for the duration noted, with continued benefit from investigational product: 1. P1093 parent study through at least Week 180; 2. P2019 parent study through at least Week 48. * Participan...
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Dolutegravir film-coated is an investigational small molecule being studied for the treatment of HIV Infections. It is currently in Phase 3 clinical development and is being evaluated in patients with HIV-1. The drug is intended for use in the infectious disease therapeutic area.
Dolutegravir film-coated is being developed by GSK plc, a biopharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HIV infections.
Dolutegravir film-coated is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 3 trial involving 100 participants with HIV infections.
Dolutegravir film-coated is associated with one completed Phase 3 clinical trial registered as NCT03016533. This trial, titled "Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019," enrolled 100 participants across multiple countries including the United States, Botswana, Brazil, South Africa, Tanzania, Thailand, and Zimbabwe.
Dolutegravir film-coated refers to a specific formulation of the drug dolutegravir, which is an integrase inhibitor used in the treatment of HIV. The film-coated version is being studied in a Phase 3 clinical trial for HIV infections, and it is developed by GSK plc.