HIV Infections
Conditions
Keywords
VH4011499, Cabotegravir (CAB), Dolutegravir/Lamivudine (DTG/3TC), Efficacy, People with HIV (PWH)
Brief summary
The purpose of this Phase 2b study is to evaluate the efficacy and therapeutic window of chronically dosed VH4011499 paired with an integrase strand transfer inhibitor (INSTI). This study will explore 4 different regimens of VH4011499 when paired with cabotegravir (CAB) as an initial two-drug regimen.
Interventions
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be at least 18 years of age (or older, if required for adults by local regulations). * Screening CD4+ T-cell count ≥ 200 cells/µL. * Documented HIV-1 infection and screening plasma HIV-1 RNA ≥ 1 000 and ≤ 100 000 copies/mL. * Treatment-naïve. Prior use of oral pre-exposure prophylaxis (PrEP) or oral post-exposure prophylaxis (PEP) that is not INSTI or CAI based is permitted. * Body weight ≥ 50.0 kg (110 lbs) for participants assigned male at birth and ≥ 45.0 kg (99 lbs) for participants assigned female at birth. * Agrees to adequate birth control if a participant of childbearing potential
Exclusion criteria
* Participants with acute HIV-1 infection * Prior exposure to any HIV-1 capsid inhibitor or any HIV-1 INSTI for any reason is prohibited. * Participants with known or suspected presence of major virologic resistance mutations to study drugs * Unstable liver disease * Participants with HCV co-infection * Participant has evidence of chronic active HBV infection * Clinically significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm | At Month 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with plasma HIV-1 RNA <50 copies/mL as per FDA snapshot algorithm | At Month 13 and Month 25 | — |
| Number of participants with plasma HIV-1 RNA <50 copies/mL as per observed data | At Month 7, Month 13 and Month 25 | — |
| Change from baseline (Day 1) in cluster of differentiation (CD) 4+ T-cell count | At Month 7, Month 13 and Month 25 | — |
| Number of participants with injection site reaction adverse events of special interest (ISR AESIs) by grade | Through Month 7, Month 13 and Month 25 | The ISR AESIs will be graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening. |
| Duration of ISR AESIs by grade | Through Month 7, Month 13 and Month 25 | The ISR AESIs will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening. |
| Number of participants with serious adverse events (SAEs) by grade | Through Month 7, Month 13 and Month 25 | An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment. The SAEs will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death. |
| Number of participants with adverse events (AEs) leading to study treatment discontinuation, by grade | Through Month 7, Month 13 and Month 25 | The AEs leading to treatment discontinuation will be graded using the DAIDS grading table Version 2.1, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death. |
| Plasma concentrations of VH4011499 | Through Months 7, 13 and 25 | — |
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed