Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cabotegravir/Rilpivirine · 1 trial · 1 indication
Proportion with plasma HIV-1 viral load (VL) \<50 c/mL at 12 months (by Food and Drug Administration \[FDA\] snapshot algorithm)
| Arm | Type | Description |
|---|---|---|
| CAB LA + RPV LA Arm | EXPERIMENTAL | The first 4 weeks of the treatment differ depending on whether participant opts for direct to injection (DTI) or Oral lead-in (OLI). DTI: participants will remain on daily oral ART for 4weeks after randomization and will receive the 1st injection of IM CAB LA 600mg+RPV LA 900mg at the Month 1 visit. 2nd injections administered at Month 2, followed by maintenance injections every 2 months (Q2M) OLI: participants will receive the study intervention in 2 phases: 1. Participants will receive CAB 30mg+RPV 25mg OD for 4weeks to be taken daily with food. The purpose of the optional OLI Phase is to allow an opportunity for participants to assess tolerability of the combination prior to administration of the injectables. There is no proven benefit to this approach 2. After 4weeks participants return for the Month 1 visit to receive the 1st IM CAB LA 600mg+RPV LA 900mg injections. The 2nd injections administered at Month 2 and then continuation injections will be administered Q2M |
| ART Group | ACTIVE_COMPARATOR | Participants will take a daily oral combination of 2 NRTIs plus DTG 50mg. Ideally, the single tablet fixed-dose combination regimen of (tenofovir disoproxil fumarate \[TDF\] 300 mg + lamivudine \[3TC\] 300 mg (or emtricitabine \[FTC\] 200 mg) + DTG 50 mg) will be used as per local country guidelines up to Month 24. If there are preexisting reasons why TDF or 3TC cannot be used as the NRTI backbone then alternative NRTIs are acceptable. Participants will be permitted to switch daily oral ART drugs in case of toxicity, after discussion with the coordinating center. |
| Name | Type | Description |
|---|---|---|
| Cabotegravir/Rilpivirine | DRUG | injectable long-acting cabotegravir 600mg + long-acting rilpivirine 900mg administered every 2 months |
| Antiretroviral | DRUG | Oral antiretroviral therapy in the form of 2NRTIs + dolutegravir 50mg administered daily |
Inclusion Criteria: 1. 18 years of age and above 2. HIV-1 infection confirmed in clinic records or by study team. 3. Two consecutive HIV-1 VL \<200 copies/mL ≥3 months apart prior to randomization. 4. On an oral regimen of 2NRTI + DTG as part of first line ART 5. Is identified as a participant with...
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