Antiretroviral Therapy for Acute HIV Infection
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|ClinicalTrials.gov Identifier: NCT03877536|
Recruitment Status : Withdrawn (Feeder cohort study closed.)
First Posted : March 15, 2019
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Genvoya 150Mg-150Mg-200Mg-10Mg Tablet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||prospective, open-label study|
|Masking:||None (Open Label)|
|Official Title:||Antiretroviral Therapy for Acute HIV Infection|
|Estimated Study Start Date :||March 17, 2019|
|Estimated Primary Completion Date :||September 14, 2023|
|Estimated Study Completion Date :||September 14, 2025|
Experimental: Genvoya 150Mg-150Mg-200Mg-10Mg Tablet
Genvoya® (Elvitegravir, corbiscistat, Emtricitabine and Tenofovir Alafenamide): once a day antiretroviral pill starting within 1 week of enrollment.
Drug: Genvoya 150Mg-150Mg-200Mg-10Mg Tablet
Participants will receive 1 tablet per day throughout study duration (96 weeks).
- Plasma viral load [ Time Frame: Measured at 48 weeks after enrollment ]The number of study participants with plasma viral load <50 copies/mL
- Plasma viral load [ Time Frame: Measured at 96 weeks after enrollment ]The number of study participants with plasma viral load <50 copies/mL
- Drug-related AEs and SAEs [ Time Frame: Measured through week 96 ]Occurrence of drug-related adverse events and serious adverse events at any time from enrollment up to 96 weeks after enrollment early HIV infection.
- Treatment Discontinuation for AEs up to 96 weeks [ Time Frame: Measured through week 96 ]Tolerability of treatment as measured by treatment discontinuation for AEs up to 96 weeks
- CD4+ T cell count change [ Time Frame: Measured over 48 weeks ]CD4+ T cell count change over first 48 weeks as compared to baseline.following the initiation of Genvoya®
- Frequency of HIV-related illnesses [ Time Frame: Measured through week 96 ]Frequency of HIV-related illnesses (including acute retroviral syndrome)
- Duration of HIV-related illnesses [ Time Frame: Measured through week 96 ]Duration of HIV-related illnesses (including acute retroviral syndrome)
- Changes in HIV-specific immune responses over time [ Time Frame: Measured through week 96 ]Description of changes in HIV-specific immune responses over time as characterized by intracellular cytokine staining (ICS)
- Host humoral (IgG) responses [ Time Frame: Measured through week 96 ]Characterization of evolution in host humoral (IgG) responses to HIV envelope over time including development of neutralizing antibody responses
- Markers of Immune Activation [ Time Frame: Measured through week 96 ]Description of markers of immune activation (soluble and cellular markers) by ICS.
- HIV reservoir size [ Time Frame: Measured through week 96 ]Evaluation of the HIV reservoir size by measurement of 1) single copy HIV RNA quantification in samples with HIV RNA <50 copies/mL and 2) total HIV DNA and integrated HIV DNA in peripheral blood
- Neuropsychological battery performance [ Time Frame: Measured through week 96 ]Evaluation of neuropsychological battery performance at week 48 and 96; and to later compare to RV 217 data from pre-infection and baseline early or acute HIV infection timepoints.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877536
|Makerere University--Walter Reed Project (MUWRP)|
|Study Chair:||Christina Polyak, MD, MPH||Henry M. Jackson Foundation in support of MHRP|