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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

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ClinicalTrials.gov Identifier: NCT02016924
Recruitment Status : Recruiting
First Posted : December 20, 2013
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

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 human immunodeficiency virus-1 (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 pediatric participants weighing ≥ 25 to < 40 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 pediatric participants weighing ≥ 25 to < 40 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 pediatric participants weighing ≥ 25 to < 40 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 pediatric participants weighing ≥ 14 to < 25 kg (≥ 2 years of age)
  • To evaluate the steady-state PK of TAF and confirm the dose of F/TAF in HIV-1 infected pediatric participants weighing ≥ 14 to < 25 kg (≥ 2 years of age)
  • To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected pediatric participants weighing ≥ 14 to < 25 kg (≥ 2 years of age)

Cohort 4:

The primary objectives are:

  • To evaluate the steady-state PK of ATV and confirm the dose of ATV/co in HIV-1 infected pediatric participants weighing ≥ 5 to < 14 kg (≥ 3 months of age; Groups 2 to 4)
  • To evaluate the steady-state PK of TAF and confirm the dose of F/TAF in HIV-1 infected pediatric participants weighing ≥ 3 to < 14 kg (≥ 4 weeks of age; Groups 2 to 4)
  • To evaluate the safety and tolerability of ATV/co, DRV/co, and F/TAF through 24 weeks in HIV-1 infected pediatric participants weighing ≥ 3 to < 25 kg (≥ 4 weeks of age; Groups 1 to 4)

Cohort 5:

The primary objectives are:

  • To evaluate the steady-state PK of TAF and confirm the dose of F/TAF in HIV-1 infected pediatric participants on an unboosted third antiretroviral (ARV) regimen weighing ≥ 3 to < 14 kg (≥ 4 weeks of age)
  • To evaluate the safety and tolerability of F/TAF in combination with a third unboosted agent through 24 weeks in HIV-1 infected pediatric participants weighing ≥ 3 to < 14 kg (≥ 4 weeks of age)

Condition or disease Intervention/treatment Phase
Acquired Immune Deficiency Syndrome (AIDS) HIV Infections Drug: ATV Drug: DRV Drug: Cobicistat Drug: BR Drug: F/TAF Drug: LPV/r Drug: Third Unboosted Drug Drug: Cobicistat TOS Drug: F/TAF TOS Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 16, 2014
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Cohort 1: Part A and Part B
Participants ages 12 to <18 years old will receive cobicistat 150 mg with either ATV or DRV plus background regimen (BR). The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents.
Drug: ATV
Capsules administered once daily according to dosing recommendations per product monograph
Other Name: Reyataz®

Drug: DRV
Tablets administered once daily according to dosing recommendations per product monograph
Other Name: Prezista®

Drug: Cobicistat
Tablets administered orally once daily with food
Other Names:
  • GS-9350
  • Tybost®

Drug: BR
Background Regimen (BR) include Food and Drug Administration (FDA)-approved nucleos(t)ide reverse transcriptase inhibitors (NRTIs) including zidovudine (ZDV), stavudine (d4T), didanosine (ddI), abacavir (ABC), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), lamivudine (3TC), and emtricitabine (FTC).

Experimental: Cohort 2 (Group 1)

After Protocol Amendment 9, Cohort 2 weight range will be modified to ≥ 25 to < 40 kg.

Group 1 will be the current weight/age range for Cohort 2, participants aged 6 to <12 years old and ≥ 25 to < 35 kg. They will receive cobicistat (co) 150 mg and emtricitabine/tenofovir alafenamide (F/TAF) 20/25 mg with either ATV or DRV.

Drug: ATV
Capsules administered once daily according to dosing recommendations per product monograph
Other Name: Reyataz®

Drug: DRV
Tablets administered once daily according to dosing recommendations per product monograph
Other Name: Prezista®

Drug: Cobicistat
Tablets administered orally once daily with food
Other Names:
  • GS-9350
  • Tybost®

Drug: F/TAF
Tablets administered orally once daily
Other Name: Descovy®

Experimental: Cohort 2 (Group 2)

After Protocol Amendment 9, Cohort 2 weight range will be modified to ≥ 25 to < 40 kg.

Group 2 will be the new weight range for Cohort 2, participants aged 6 to <12 years old and ≥ 35 to < 40 kg. They will receive cobicistat (co) 150 mg and emtricitabine/tenofovir alafenamide (F/TAF) 20/25 mg with DRV

Drug: DRV
Tablets administered once daily according to dosing recommendations per product monograph
Other Name: Prezista®

Drug: Cobicistat
Tablets administered orally once daily with food
Other Names:
  • GS-9350
  • Tybost®

Drug: F/TAF
Tablets administered orally once daily
Other Name: Descovy®

Experimental: Cohort 3
Participants ages ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV.
Drug: ATV
Capsules administered once daily according to dosing recommendations per product monograph
Other Name: Reyataz®

Drug: DRV
Tablets administered once daily according to dosing recommendations per product monograph
Other Name: Prezista®

Drug: Cobicistat
Tablets administered orally once daily with food
Other Names:
  • GS-9350
  • Tybost®

Drug: F/TAF
Tablets administered orally once daily
Other Name: Descovy®

Experimental: Cohort 4 (Group 1)
Participants age ≥ 4 weeks old weighing 14 to < 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS.
Drug: ATV
Capsules administered once daily according to dosing recommendations per product monograph
Other Name: Reyataz®

Drug: DRV
Tablets administered once daily according to dosing recommendations per product monograph
Other Name: Prezista®

Drug: LPV/r
Solution administered orally

Drug: Cobicistat TOS
Tablets for oral suspension
Other Names:
  • GS-9350
  • Tybost®

Drug: F/TAF TOS
Tablets for oral suspension
Other Name: Descovy®

Experimental: Cohort 4 (Group 2)
Participants age ≥ 4 weeks old weighing 10 to < 14 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 60/7.5 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Drug: ATV
Capsules administered once daily according to dosing recommendations per product monograph
Other Name: Reyataz®

Drug: LPV/r
Solution administered orally

Drug: Cobicistat TOS
Tablets for oral suspension
Other Names:
  • GS-9350
  • Tybost®

Drug: F/TAF TOS
Tablets for oral suspension
Other Name: Descovy®

Experimental: Cohort 4 (Group 3)
Participants age ≥ 4 weeks old weighing 6 to < 10 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 30/3.75 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Drug: ATV
Capsules administered once daily according to dosing recommendations per product monograph
Other Name: Reyataz®

Drug: LPV/r
Solution administered orally

Drug: Cobicistat TOS
Tablets for oral suspension
Other Names:
  • GS-9350
  • Tybost®

Drug: F/TAF TOS
Tablets for oral suspension
Other Name: Descovy®

Experimental: Cohort 4 (Group 4)
Participants age ≥ 4 weeks old weighing 3 to < 6 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 15/1.88 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Drug: ATV
Capsules administered once daily according to dosing recommendations per product monograph
Other Name: Reyataz®

Drug: LPV/r
Solution administered orally

Drug: Cobicistat TOS
Tablets for oral suspension
Other Names:
  • GS-9350
  • Tybost®

Drug: F/TAF TOS
Tablets for oral suspension
Other Name: Descovy®

Experimental: Cohort 5 (Group 1)
Participants ages ≥ 4 weeks old weighing ≥ 10 to < 14 kg will receive F/TAF TOS 60/7.5 mg, once daily with the third unboosted drug.
Drug: Third Unboosted Drug
ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.

Drug: F/TAF TOS
Tablets for oral suspension
Other Name: Descovy®

Experimental: Cohort 5 (Group 2)
Participants ages ≥ 4 weeks old weighing ≥ 6 to < 10 kg will receive F/TAF TOS 30/3.75 mg, once daily with the third unboosted drug.
Drug: Third Unboosted Drug
ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.

Drug: F/TAF TOS
Tablets for oral suspension
Other Name: Descovy®

Experimental: Cohort 5 (Group 3)
Participants ages ≥ 4 weeks old weighing ≥ 3 to < 6 kg will receive F/TAF TOS 15/1.88 mg, once daily with the third unboosted drug.
Drug: Third Unboosted Drug
ATV (administered orally), DRV (administered orally), and LPV/r (administered orally) would be general list but unspecified for sites.

Drug: F/TAF TOS
Tablets for oral suspension
Other Name: Descovy®




Primary Outcome Measures :
  1. Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV [ Time Frame: Predose on Day 1, and postdose up to Week 48 ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). AUCtau for ATV (Cohorts 1 Part A, 2, 3, and 4 [Groups 2 to 4]); DRV (Cohorts 1 Part A, 2, and 3); TAF (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 [Groups 1 to 3] taking F/TAF); and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 [Groups 1 to 3] taking F/TAF) will be reported.

  2. Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) Through Week 24 [ Time Frame: First dose date up to Week 24 plus 30 days (Cumulative data through Week 24) ]
  3. Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities Through Week 24 [ Time Frame: First dose date up to Week 24 plus 30 days (Cumulative data through Week 24) ]

Secondary Outcome Measures :
  1. PK Parameter: Ctau of ATV, DRV, TAF, and TFV [ Time Frame: Predose on Day 1, and postdose up to Week 48 ]
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Ctau for ATV (cohorts 1, 2, 3, and 4 (Groups 2 to 4)), DRV (cohorts 1, 2, and 3), COBI (except Cohort 5), FTC and TFV (cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.

  2. PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV [ Time Frame: Predose on Day 1, and postdose up to Week 48 ]
    Cmax is defined as the maximum observed concentration of drug. Cmax for ATV (Cohorts 1, 2, 3, and 4 [Groups 2 to 4]) and DRV (Cohorts 1, 2, and 3); for COBI (except Cohort 5); for TAF, FTC and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.

  3. PK Parameter: CL/F of ATV, DRV, COBI, TAF, FTC and TFV [ Time Frame: Predose on Day 1, and postdose up to Week 48 ]
    CL/F is defined as the apparent oral clearance following administration of the drug. CL/F for ATV (Cohorts 1, 2, 3, and 4 [Groups 2 to 4]) and DRV (Cohorts 1, 2, and 3); for COBI (except Cohort 5); for TAF, FTC and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.

  4. PK Parameter: Vz/F of COBI, TAF, FTC and TFV [ Time Frame: Predose on Day 1, and postdose up to Week 48 ]
    Vz/F is defined as the apparent volume of distribution of the drug. Vz/F for COBI (Except Cohort 5); for TAF (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF); for FTC and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.

  5. PK Parameter: AUCtau of COBI, FTC and TFV [ Time Frame: Predose on Day 1, and postdose up to Week 48 ]
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). AUCtau for COBI (Except Cohort 5); for FTC and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.

  6. PK Parameter: AUClast of TAF, FTC and TFV [ Time Frame: Predose on Day 1, and postdose up to Week 48 ]
    AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. AUClast for TAF (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF); for FTC and TFV (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.

  7. PK Parameter: Clast of TAF [ Time Frame: Predose on Day 1, and postdose up to Week 48 ]
    Clast is defined as the the last observed quantifiable concentration of the drug in plasma. Clast for TAF (Cohorts 2, 3, 4 [Groups 1 to 4] and 5 taking F/TAF) will be reported.

  8. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to Week 48 plus 30 days (Cumulative data through Week 48) ]
  9. Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values [ Time Frame: First dose date up to Week 48 plus 30 days (Cumulative data through Week 48) ]
  10. Percentage of Participants with HIV-1 RNA < 50 Copies/mL at Week 24 and as Defined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 24 ]
  11. Percentage of Participants with HIV-1 RNA < 50 Copies/mL at Week 48 and as Defined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 48 ]
  12. Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 24 [ Time Frame: Baseline, Week 24 ]
  13. Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 48 [ Time Frame: Baseline, Week 48 ]
  14. Change from Baseline in Percentage of CD4+ Cells at Week 24 [ Time Frame: Baseline, Week 24 ]
  15. Change from Baseline in Percentage of CD4+ Cells at Week 48 [ Time Frame: Baseline, Week 48 ]
  16. Acceptability of COBI and F/TAF as Measured by Palatability Score [ Time Frame: Week 48 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Weeks to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • HIV-1 infected, virologically suppressed males and females Age ≥ 4 weeks to < 18 years (according to requirements of enrolling Cohort).
  • Body weight at screening ≥ 25 to < 40 kg (Cohort 2); ≥ 14 to < 25 kg (Cohort 3); ≥ 3 to < 25 kg (Cohort 4); ≥ 3 to < 14 kg (Cohort 5)
  • Stable antiretroviral (ARV) regimen for a minimum of 3 months prior to the screening visit.

    • Participants enrolled prior to implementation of Amendment 7: 2 NRTIs and ATV/r once daily or DRV/r once daily or twice daily.
    • Participants enrolled after the implementation of Amendment 9:

      • Cohorts 2, 3 and 4 (Group 1): 2 NRTIs plus a third agent per local prescribing guidelines. Participants will switch from their current third agent to ATV or DRV at Day 1. Participants taking DRV must be on once-daily dosing or must switch to once daily at or prior to Day 1. Cohort 4 (Group 1), participants may also switch their current third agent to LPV/r at Day 1. Participants will switch their NRTI backbone to F/TAF.
      • Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): 2 NRTIs plus a third agent per local prescribing guidelines or treatment naive. Participants on treatment will switch from their current third agent to ATV or LPV/r (Cohort 4 [Groups 2 to 4]), or to a third unboosted agent (Cohort 5 [Groups 1 to 3]). Participants will switch their NRTI backbone to F/TAF.
  • Participants undergoing dose modifications to their ARV regimen for growth or switching medication formulations are considered to be on a stable ARV regimen.
  • Documented plasma HIV-1 RNA for ≥ 3 months preceding the screening visit:

    • Participants enrolled after the implementation of Amendment 9:

      • For Cohorts 2, 3, and 4 (Group 1), virologically suppressed ≥ 3 months preceding the screening visit: HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
      • For Cohorts 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3), on an ARV regimen irrespective of plasma HIV-1 RNA copies or treatment naive; a participant is considered treatment naive if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment
    • For virologically suppressed participants, unconfirmed virologic elevations of HIV-1 RNA ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on 2 consecutive HIV-1 RNA tests.
  • Adequate renal function: Estimated Glomerular Filtration Rate (eGFR) ≥ 90 mL/min/1.73m2 using the Schwartz formula. If ≥ 1 year old, eGFR greater than or equal to the minimum normal value for age using the Schwartz Formula. If < 1 year old as follows:

    • Age Minimum Value for eGFR (mL/min/1.73 m2) > 28 days to ≤ 95 days 30, ≥ 96 days to ≤ 6 months 39, > 6 to < 12 months 49
  • Participants must not have documented or suspected resistance to applicable study drugs including FTC, TFV, ATV, DRV, or LPV. Participants < 14 kg (Cohorts 4 [Groups 2 to 4] and 5 [Groups 1 to 3]) with M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed.
  • Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age).
  • Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): Last dose of nevirapine or efavirenz, if applicable, ≥ 14 days prior to enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria do apply.


Information from the National Library of Medicine

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): NCT02016924


Contacts
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Contact: Gilead Study Team GSUS2160128@gilead.com

Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
Additional Information:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02016924    
Other Study ID Numbers: GS-US-216-0128
2013-001402-28 ( EudraCT Number )
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
Pediatrics
Adolescents
HIV
HIV-1
Treatment experienced
Additional relevant MeSH terms:
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Cobicistat
HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immune System Diseases
Slow Virus Diseases
Emtricitabine tenofovir alafenamide
Emtricitabine
Tenofovir
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors