Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07393659 | A Continued Access Study for Participants Transitioning From ViiV Healthcare-sponsored or ViiV Healthcare-collaborative Parent Studies for HIV Treatment | PHASE3 | NOT YET_RECRUITING | 183 | — | — | May 8, 2026 | Dec 30, 2030 | Feb 6, 2026 | - | — |
| NCT04757974 | Low-dose Fostemsavir Extended Release Relative Bioavailability Study | PHASE1 | COMPLETED | 32 | — | — | Mar 5, 2021 | Jul 31, 2021 | Sep 22, 2021 | 1 | United States |
A SAE is defined as any untoward medical occurrence that, at any dose, results in results in death, is life- threatening, requires inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes or a suspected transmission of any infectious agent via an authorized medicinal product.
An adverse event (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. An AESI is defined as an AE of a scientific and medical concern specific to the study intervention, which may require further investigation in order to characterize and understand it.
| Arm | Type | Description |
|---|---|---|
| Continued Access Group | EXPERIMENTAL | Participants with HIV-1 who received the study intervention and completed the protocol-defined treatment period in ViiV Healthcare-sponsored or ViiV Healthcare-collaborative parent studies (2020-001029-30, 2020-001426-57), and who continue to receive the study intervention from their respective parent study. |
| Part 1: Treatment sequence ABC | EXPERIMENTAL | Participants will receive FTR 3×200 mg ER tablets (Treatment A) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 2 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 3. |
| Part 1: Treatment sequence BCA | EXPERIMENTAL | Participants will receive FTR 3×200 mg ER tablets (Treatment B) in Period 1 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 3. |
| Part 1: Treatment sequence CAB | EXPERIMENTAL | Participants will receive FTR 600 mg ER tablet in Period 1 (Treatment C, reference) followed by FTR 3×200 mg ER tablets (Treatment A) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 3. |
| Part 1: Treatment sequence ACB | EXPERIMENTAL | Participants will receive FTR 3×200 mg ER tablets (Treatment A) in Period 1 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 3. |
| Part 1: Treatment sequence BAC | EXPERIMENTAL | Participants will receive FTR 3×200 mg ER tablets (Treatment B) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 2 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 3. |
| Part 1: Treatment sequence CBA | EXPERIMENTAL | Participants will receive FTR 600 mg ER tablet (Treatment C, reference) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 3. |
| Part 2: Treatment sequence DE | EXPERIMENTAL | Participants will receive the selected low-dose formulation of FTR 3 × 200 mg ER tablets in a fasted state (Treatment D) in Period 1 and following a high fat high calorie meal (Treatment E) in Period 2. |
| Part 2: Treatment sequence ED | EXPERIMENTAL | Participants will receive the selected low-dose formulation of FTR 3 × 200 mg ER tablets following a high fat high calorie meal (Treatment E) in Period 1 and in a fasted state (Treatment D) in Period 2. |
| Name | Type | Description |
|---|---|---|
| Fostemsavir | DRUG | Participants receive oral tablets with the dosages depending on the weight of the participants. |
| Dolutegravir (DTG)/ Lamivudine (3TC) | DRUG | Participants receive oral tablets with the dosages depending on the weight of the participants. |
| Fostemsavir 600 mg | DRUG | Fostemsavir tablets will be administered via oral route. |
| Fostemsavir 200 mg | DRUG | Fostemsavir tablets will be administered via oral route. |
Inclusion Criteria: Participants are eligible to be included in this study only if all the following criteria apply: * Investigator confirmation of the participant's continued clinical benefit from the parent study intervention and the participant's completion of the protocol-defined treatment per...