Approval Probability
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Also known as Dolutegravir
Dolutegravir+ Lamivudine · 2 trials · 1 indication
Participants were classified as "HIV-1 RNA \<50 c/mL" using an ITT-E missing = Failure analysis. Participants were classified as 'HIV-1 RNA \< 50 c/mL' if the last viral load within the Week 24 visit window was \<50/c/mL, regardless of the ART regimen they were on at the time of viral load assessment (in other words switch from DTG plus 3TC fixed-dose combination \[FDC\] to another ART was not penalized) and as HIV-1 RNA \>= 50 c/mL in all other cases (i.e. last viral load within Week 24 visit window \>= 50 c/mL, on study but having missing viral load data at Week 24, discontinued early from study due to lost to follow-up (LFU), withdrew consent or any other reason). Confidence intervals (CI) were calculated based on the Exact Clopper-Pearson method. Percentage of participants with plasma HIV-1 RNA \< 50 c/mL based on ITT-E missing = Failure analysis at Week 24 are presented.
| Arm | Type | Description |
|---|---|---|
| Participants receiving Dolutegravir + Lamivudine FDC | EXPERIMENTAL | Participants will receive DTG 50mg and 3TC 300 mg FDC tablet orally once daily (OD) with or without food |
| Dolutegravir(DTG)/Rilpivirine (RPV) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Dolutegravir + Lamivudine FDC | DRUG | Dolutegravir + Lamivudine FDC is available as white oval film-coated tablets which are packed in high density polyethylene (HDPE) bottles with induction seals and child-resistant closures. Each 60 milliliter (mL) bottle contains 30 tablets |
| Dolutegravir/Rilpivirine FDC | DRUG | Dolutegravir/Rilpivirine will be administered. |
Inclusion Criteria: * Eligible participants must be able to understand and comply with protocol requirements, instructions, and restrictions. * Eligible participants must be likely to complete the study as planned. * Eligible participants must be considered appropriate candidates for participation ...
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Dolutegravir is an investigational small molecule being developed for the treatment of HIV infections, including Human Immunodeficiency Virus I, HIV Infections, and co-infections with Hepatitis and Herpesviridae. It is currently in Phase 3 clinical development.
Dolutegravir is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV infections.
Dolutegravir is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. Clinical trials are ongoing to assess its effectiveness in treating HIV infections.
Dolutegravir has been studied in multiple clinical trials, including NCT01353716, NCT01425099, NCT01762995, and NCT02738931. These trials have investigated its pharmacokinetics, drug interactions, and bioavailability in healthy volunteers and individuals with HIV.
Dolutegravir is also known as Dolutegravir/Rilpivirine FDC, Dolutegravir/Rilpivirine, Dolutegravir/Lamivudine (DTG/3TC), and Dolutegravir/Lamivudine. These names refer to fixed-dose combinations that include dolutegravir as a component.
Dolutegravir is a small molecule that targets HIV integrase, an enzyme essential for viral replication. By inhibiting this enzyme, it prevents the virus from integrating its genetic material into host cells, thereby reducing viral load in infected individuals.