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Report for Clinical Trial NCT01967940

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3, Two-Part Study to Evaluate the Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults

The primary objective of this study is to evaluate the efficacy of tenofovir alafenamide (TAF) versus placebo, each administered with the existing, failing antiretroviral (ARV) regimen. There are 2 parts to this study: Part 1 and Part 2. Part 1 consists of 2 cohorts, starting with a sentinel cohort, in which participants will be enrolled to receive open-label TAF in addition to their current failing ARV regimen. This cohort will then be followed by a randomized, double-blind, cohort to compare the addition of TAF or placebo in HIV-1 positive adults who are failing their current ARV regimen. In Part 2, all participants who complete Part 1 of the study will discontinue their failing ARV regimen and TAF or placebo for a 14-day washout period. Following the washout period, all participants who received TAF in Part 1 and have a > 0.5 log10 decline in HIV-1 RNA will receive elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) plus atazanavir (ATV) once daily for 48 weeks. Participants who received TAF who have a ≤ 0.5 log10 decline in HIV-1 RNA will be discontinued from the study and will not be eligible to continue into Part 2 of the study. All participants who received placebo in Part 1 will be eligible to participate in Part 2 regardless of their viral load change. After completion of Part 2, all participants will be eligible to continue to receive E/C/F/TAF plus ATV in the extension phase until E/C/F/TAF becomes commercially available, or until Gilead Sciences terminates development of E/C/F/TAF in the applicable country.

NCT01967940 HIV HIV Infections Acquired Immunodeficiency Syndrome
MeSH: HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes
HPO: Immunodeficiency

5 Interventions

Name: TAF

Description: 25 mg tablet administered orally once daily with food

Type: Drug

Part 1 Randomized Cohort (TAF) Part 1 Sentinel Cohort (TAF)

Name: Placebo

Description: Tablets to match TAF administered orally once daily with food

Type: Drug

Part 1 Randomized Cohort (Placebo)

Name: E/C/F/TAF

Description: 150/150/200/10 mg STR administered orally once daily with food

Type: Drug

Part 2 E/C/F/TAF+ATV

Name: Current failing ARV regimen

Description: Participants will continue taking their current ARV regimen as prescribed in Part 1.

Type: Drug

Part 1 Randomized Cohort (Placebo) Part 1 Randomized Cohort (TAF) Part 1 Sentinel Cohort (TAF)

Name: ATV

Description: 300 mg tablet administered orally once daily.

Type: Drug

Part 2 E/C/F/TAF+ATV


Primary Outcomes

Measure: Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10

Time: Day 10

Secondary Outcomes

Measure: Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10

Time: Baseline; Day 10

Measure: Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 24

Time: Up to Week 24

Measure: Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 48

Time: Up to Week 48

Measure: Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 24

Time: Up to Week 24

Measure: Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 48

Time: Up to Week 48

Description: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Measure: Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24

Time: Week 24

Description: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Measure: Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48

Time: Week 48

Description: The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Measure: Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24

Time: Week 24

Description: The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Measure: Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48

Time: Week 48

Measure: Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 24

Time: Baseline; Week 24

Measure: Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 48

Time: Baseline; Week 48

Measure: Part 2: Change From Baseline in CD4+ Cell Count at Week 24

Time: Baseline; Week 24

Measure: Part 2: Change From Baseline in CD4+ Cell Count at Week 48

Time: Baseline; Week 48

Measure: Part 2: Change From Baseline in CD4+ Percentage at Week 24

Time: Baseline; Week 24

Measure: Part 2: Change From Baseline in CD4+ Percentage at Week 48

Time: Baseline; Week 48

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 Q151M

Key Exclusion Criteria: - A new AIDS-defining condition diagnosed within the 30 days prior to screening - Hepatitis B surface antigen (HBsAg) positive - Hepatitis C antibody positive (individuals with positive hepatitis C virus (HCV) antibody and without detectable HCV RNA are permitted to enroll) - History of integrase inhibitor use - Screening or historical genotype reports shows Q151M or T69ins or more than 3 TAMs. --- Q151M ---



HPO Nodes


HPO:
Immunodeficiency
Genes 257
LETM1 NFKB2 EPG5 BCL10 AK2 MS4A1 RTEL1 IFNGR2 LIG4 NFKB1 AGPAT2 FCGR3A NFKB2 RNF168 TERT ZBTB24 CHD1 ATRX ANTXR2 PKP1 WIPF1 NOP10 GATA2 HYOU1 XRCC4 SDHD NHP2 IRAK4 CORO1A TBX1 RBCK1 MALT1 TNFRSF4 LAT CD247 IL2RG PARN EPG5 BSCL2 PARN AK2 IRF7 ICOS GATA1 TNFSF12 USB1 ACTB SMARCAL1 UNG TYK2 IL21R TTC7A IL2RB STAT1 IKBKG FGFRL1 FOXN1 HIRA CCDC47 CLCA4 ACD TNFRSF13B MYC AICDA IRAK4 CD3G FCN3 CYBA CTBP1 CHD1 LAMTOR2 LIG4 CAVIN1 SIK3 IL7R LCK ICOS NPM1 MYD88 ORAI1 RAG2 CARD11 PTEN IGHM PTPRC LAMTOR2 RAG1 PGM3 ARVCF TNFRSF1B TNFRSF13C IRF8 SEC24C IL2RG COG6 IKBKG CD28 DKC1 POLE CR2 ADA JMJD1C TCF3 AP3D1 MBTPS2 SHANK3 HELLS COMT UFD1 RAG2 TTC37 IFNGR1 BCL11B CD19 CARD9 BLNK PRKDC CR2 BUB1B MEIS2 RAG1 SDHC NSD2 CTPS1 DOCK2 CDCA7 LMNB2 IRF2BP2 CD79B TERC LYST CD19 FOS CD3E TFRC NCF1 NHEJ1 IRF8 CTC1 LYST LRBA DNMT3B CAV1 CRKL STX1A MAGT1 CPLX1 TNFRSF13B MMUT DCLRE1C RMRP GP1BB CTLA4 DCLRE1C SKIV2L LRRC8A CD81 ICOS TGFB1 XIAP XRCC4 IL7R TTC7A SKIV2L TBCE RTEL1 IGLL1 NCF2 IL21 UNC119 SIN3A WHCR TNFRSF13C ISG15 JAK3 CD79A RAG1 USP8 CD19 CR2 STAT1 CD3D CFTR CYBB IL12RB1 WAS AKT1 IL2RA HBB IKBKB ATM STAT1 STK4 PRKCD ACP5 IKBKG SH2D1A MTHFD1 CDC42 ADA2 PGM3 RAG1 XIAP MAPK1 PIK3R1 SLC46A1 CHD7 MS4A1 FOXN1 RREB1 CDH23 KLLN WRAP53 CD40LG SEC23B ZBTB24 PIK3CA BTK FRAS1 TINF2 RAC2 IKZF1 RAB27A DKC1 DCTN4 TINF2 CD81 DKC1 RAG2 PRPS1 NFKB1 IKBKG IL2RG BCR UROS TNFRSF13C POLE SPATA5 TNFSF12 SDHB ADA CUL4B PIK3R1 STIM1 PIK3CD IL12B SP110 NFE2L2 PPARG TBX1 RNF168 AGL RTEL1 RMRP TERT CD40 DNMT3B