This study will evaluate the virologic effect, safety and tolerability of Genvoya® in adults during early acute HIV infection.
This is a prospective, open-label study to describe the effects of early antiretroviral (ART) therapy on 1) viral load, 2) safety and tolerability of Genvoya®, 3) clinical outcomes and secondarily on HIV-specific immune responses. This study is a sub-study of RV 217 that will recruit participants with incident HIV diagnoses from the parent RV 217 cohort. Potential RV 392 volunteers will be recruited from the RV 217 ECHO cohort if they have been diagnosed with incident HIV Infection. Screening procedures for HIV in RV 217 are designed to identify participants during acute HIV infection (AHI) or early HIV infection. Participants will initiate Genvoya®, a once a day antiretroviral pill within 1 week of enrollment. RV 392 follow-up visits will largely overlap with RV 217 visits for the study duration of 96 weeks, but additional visits will occur early after initiation of Genvoya®. RV 392 participants will remain co-enrolled in RV 217 (i.e., RV 217 visits also continue); blood collection will be coordinated by the RV 392 team by prioritizing safety labs and then research labs within the allotted blood volumes while still meeting scientific objectives for both RV 217 and RV 392. Blood tests that are required for both protocols will only be collected once and will not be duplicated across the two protocols.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Participants will receive 1 tablet per day throughout study duration (96 weeks).
Makerere University--Walter Reed Project (MUWRP)
Kampala, Uganda
Plasma viral load
The number of study participants with plasma viral load \<50 copies/mL
Time frame: Measured at 48 weeks after enrollment
Plasma viral load
The number of study participants with plasma viral load \<50 copies/mL
Time frame: Measured at 96 weeks after enrollment
Drug-related AEs and SAEs
Occurrence of drug-related adverse events and serious adverse events at any time from enrollment up to 96 weeks after enrollment early HIV infection.
Time frame: Measured through week 96
Treatment Discontinuation for AEs up to 96 weeks
Tolerability of treatment as measured by treatment discontinuation for AEs up to 96 weeks
Time frame: Measured through week 96
CD4+ T cell count change
CD4+ T cell count change over first 48 weeks as compared to baseline.following the initiation of Genvoya®
Time frame: Measured over 48 weeks
Frequency of HIV-related illnesses
Frequency of HIV-related illnesses (including acute retroviral syndrome)
Time frame: Measured through week 96
Duration of HIV-related illnesses
Duration of HIV-related illnesses (including acute retroviral syndrome)
Time frame: Measured through week 96
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.