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CobicistatWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)

Name (Synonyms) Correlation
drug4 0.12% Chlorhexidine oral/nasal rinse Wiki 1.00
drug2181 Saline oral/nasal rinse Wiki 1.00
drug89 ATV Wiki 1.00
drug307 BR Wiki 1.00
drug705 DRV Wiki 1.00
drug6 0.5% Povidone/Iodine oral/nasal rinse Wiki 1.00

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D000163 Acquired Immunodeficiency Syndrome NIH 0.58
D015658 HIV Infections NIH 0.41
D007153 Immunologic Deficiency Syndromes NIH 0.41

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002721 Immunodeficiency HPO 0.41

There is one clinical trial.

Clinical Trials

1 A Phase 2/3, Multicenter, Open-label, Multicohort Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected, Virologically Suppressed Pediatric Participants

Cohort 1: The primary objectives are: - To evaluate the steady-state pharmacokinetics (PK) of Atazanavir (ATV) and Darunavir (DRV) and confirm the dose of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co) in HIV-1 infected, virologically suppressed adolescent participants weighing ≥ 25 kg (12 to < 18 years of age) - To evaluate the safety and tolerability of ATV/co or DRV/co through 24 weeks in HIV-1 infected, virologically suppressed adolescent participants weighing ≥ 25 kg (12 to < 18 years of age) Cohort 2: The primary objectives are: - To evaluate the steady-state PK of ATV and DRV and confirm the dose of ATV/co or DRV/co in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 25 to < 35 kg (6 to < 12 years of age) - To evaluate the steady-state PK of tenofovir alafenamide (TAF) and confirm the dose of emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 25 to < 35 kg (6 to < 12 years of age) - To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 25 to < 35 kg (6 to < 12 years of age) Cohort 3: The primary objectives are: - To evaluate the steady-state PK of ATV and DRV and confirm the dose of ATV/co or DRV/co in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 14 to < 25 kg (≥ 3 years of age) - To evaluate the steady-state PK of TAF and confirm the dose of F/TAF in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 14 to < 25 kg (≥ 3 years of age) - To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected, virologically suppressed pediatric participants weighing ≥ 14 to < 25 kg (≥ 3 years of age)

NCT02016924 Acquired Immune Deficiency Syndrome (AIDS) HIV Infections Drug: ATV Drug: DRV Drug: Cobicistat Drug: BR
MeSH:HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes
HPO:Immunodeficiency

Primary Outcomes

Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Measure: Pharmacokinetic (PK) Parameter: AUCtau of ATV and DRV

Time: Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10

Description: AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).

Measure: Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, and TAF for Cohorts 2 and 3

Time: Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4

Measure: Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Treatment Emergent Laboratory Abnormalities Through Week 24

Time: First dose date and up to 24 weeks plus 30 days

Secondary Outcomes

Description: Ctau is defined as the observed drug concentration at the end of the dosing interval.

Measure: PK Parameter: Ctau of ATV, DRV, and COBI for Cohort 1

Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).

Description: Cmax is defined as the maximum observed concentration of drug.

Measure: PK Parameter: Cmax of ATV, DRV, and COBI for Cohort 1

Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).

Description: CL/F is defined as the apparent oral clearance following administration of the drug.

Measure: PK Parameter: CL/F of ATV, DRV, and COBI for Cohort 1

Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).

Description: Vz/F is defined as the apparent volume of distribution of the drug.

Measure: PK Parameter: Vz/F of COBI for Cohort 1

Time: Intensive PK samples at Predose, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10. Trough PK samples at Day 1 prior to adminstering COBI and at Weeks 12, 24, and 48 (Part A), or at Weeks 4, 12, 24, 32, and 48 (Part B).

Description: Ctau is defined as the observed drug concentration at the end of the dosing interval.

Measure: PK Parameter: Ctau of ATV, DRV, COBI, FTC, and TFV for Cohorts 2 and 3

Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48

Description: Cmax is defined as the maximum observed concentration of drug.

Measure: PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV for Cohorts 2 and 3

Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48

Description: CL/F is defined as the apparent oral clearance following administration of the drug.

Measure: PK Parameter: CL/F of ATV, DRV, and TAF for Cohorts 2 and 3

Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48

Description: Vz/F is defined as the apparent volume of distribution of the drug.

Measure: PK Parameter: Vz/F of COBI and TAF for Cohorts 2 and 3

Time: Intensive PK samples at Predose 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose at Week 2 or Week 4. Trough PK samples at Weeks 8, 24, and 36, and timed PK samples (15 minutes to 3 hours post-dose) at Weeks 12, 16, and 48

Measure: The incidence of treatment-emergent AEs and treatment-emergent laboratory abnormalities through Week 48

Time: Up to 48 weeks plus 30 days

Measure: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 and as defined by the US FDA-defined snapshot algorithm

Time: Week 24

Measure: The change from baseline in CD4+ cell counts

Time: Week 24

Measure: The change from baseline in CD4+ cell counts

Time: Week 48

Measure: The change from baseline in CD4+ percentages

Time: Week 24

Measure: The change from baseline in CD4+ percentages

Time: Week 48

Measure: Acceptability of COBI and F/TAF as Measured by Palatability

Time: Day 1, and at Weeks 4 (Day 10 for Cohort 1 Part A), 24 and 48.

Related HPO nodes (Using clinical trials)

HP:0002721: Immunodeficiency
Genes 268
PIK3CA CCDC47 CTBP1 ATRX NHEJ1 BLNK CHD1 CD81 NOP10 IKBKB CD79A TNFRSF13C CD19 AICDA LIG4 CD19 IRF2BP2 LAMTOR2 IFNGR1 UNC119 IGHM TTC7A CD81 PNP SPATA5 RAG2 PKP1 WRAP53 ADA2 TTC37 FGFRL1 CLCA4 TERT RAG1 HYOU1 LAT TYK2 LRBA TTC7A NFE2L2 CD19 DCTN4 RREB1 CD40LG FRAS1 IKBKG TNFRSF13B CFTR RAG1 IRAK4 MAN2B1 CTLA4 JAK3 SHANK3 AGL IL21 ICOS PRKDC TNFRSF13C XRCC4 LIG4 CARD9 BSCL2 TBCE CTPS1 IL7R ANTXR2 MAN2B1 HELLS IL21R MALT1 CD3G LAMTOR2 AP3D1 CD40 ARVCF MBTPS2 ACP5 PTPRC NFKB2 TFRC MS4A1 MAPK1 MTHFD1 LYST ADA POLE RAG2 XIAP SDHC DNMT3B UNG BCL11B DOCK2 ORAI1 RTEL1 IL12RB1 TLR3 FOS AK2 IL2RG TRAF3 CTLA4 DCLRE1C SIN3A SLC46A1 LRRC8A AGPAT2 TINF2 DCLRE1C IRF7 GP1BB TGFB1 UFD1 PPARG LETM1 CAVIN1 ADA ICOS SP110 CD247 IL2RG IRAK4 RAC2 ICOS MMUT TICAM1 KLLN PIK3R1 WIPF1 NFKB1 RBCK1 CORO1A IRF8 STAT1 XRCC4 MEIS2 EPG5 RTEL1 ZBTB24 IKZF1 NSD2 XIAP EXTL3 NCF1 STIM1 FOXN1 MS4A1 GATA2 COG6 CRKL ISG15 COMT RAG1 NPM1 ATM WAS HBB RNF168 RMRP SKIV2L CDCA7 JMJD1C STAT1 CHD1 FOXN1 PRPS1 RAB27A CDC42 UROS BCL10 SKIV2L DKC1 TNFRSF13C DNMT3B FCGR3A HIRA DKC1 ACTB BCR TNFRSF4 ZBTB24 CDH23 SH2D1A CPLX1 CYBA PGM3 CDC42 SEC23B STK4 TBX1 CD3E CD79B CHD7 POLE ACD IGLL1 TERC IFNGR2 TNFRSF13B CD28 UNC93B1 STX1A EPG5 AKT1 TBK1 SMARCAL1 TERT CR2 IRF8 RMRP IL2RG IL12B IL2RB NFKB1 NCF2 RAG2 WHCR PARN RTEL1 SIK3 SDHB LMNB2 PIK3CD CARD11 FCN3 CAV1 TBX1 TCF3 CYBB PIK3R1 CR2 USF3 PTEN MYC TNFSF12 AK2 MAGT1 CR2 IL2RA LCK RNF168 CD3D NHP2 IKBKG SEC24C PARN NFKB2 IL7R TNFSF12 BTK LYST CUL4B USB1 BUB1B PRKCD CTC1 SPATA5 DKC1 STAT1 GATA1 TINF2 USP8 RAG1 PGM3 TNFRSF1B SDHD MYD88
Protein Mutations 37
A71V C282Y E138A F53L G190S G48V G73S I167V I47V I50L I50V I54L I54M I76V I82A I84V K20M L100I L10F L24I L33F L76V L89V L90M M184V M36I M46I N88S Q151M T74P V11I V179D V179F V32I V82A Y181I Y181V
SNP 0