Clinical Trials
AIDS
The Stanford AIDS Clinical Trial Unit (ACTU) under the direction of Dr. Philip Grant carries out research trials in HIV, AIDS and Hepatitis C in the co-infected patient. It is staffed by specialized nurses, doctors, and support staff committed to providing excellent care. The staff work with research clients and primary care physicians to coordinate the HIV care of each patient.
Trials are conducted at the Stanford ACTU located at the Stanford Medical Center.
Please see a full listing of Stanford's HIV/AIDS clinical trials at http://med.stanford.edu/clinicaltrials/.
Stanford HIV/AIDS Team:
- Philip Grant, MD, Principle Investigator
- Cindy Padilla, MS, Data Manager/Database Coordinator
- Savita Kamble, MBBS, CCRP, Clinical Research Manager
Registry
Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: E/C/F/TAF
Eligibility
Key Inclusion Criteria:
Cohort 1 (treatment-experienced switch)
- Must not have a history of known resistance to elvitegravir (EVG), tenofovir
disoproxil fumarate (TDF), or emtricitabine (FTC)
- Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels
(according to the local assay being used) in the 6 months preceding the screening
visit and have HIV-1 RNA < 50 copies/mL at screening
- Estimated glomerular filtration rate (GFR) 30-69 mL/min according to the
Cockcroft-Gault formula for creatinine clearance, using actual weight
- May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and
GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit for that
study is complete; or currently receiving Stribild® (STB) or atazanavir
(ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or
GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit for that
study is complete.
Cohort 2 (treatment-naive)
- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
- Screening genotype report provided by Gilead Sciences must show sensitivity to EVG,
FTC, and TDF
- No prior use of any approved or investigational antiretroviral drug for any length of
time, except the use for pre-exposure prophylaxis (PrEP), or post-exposure prophylaxis
(PEP), up to 6 months prior to screening
- Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine
clearance, using actual weight
All Cohorts:
All individuals must meet all of the following inclusion criteria to be eligible for
participation in this study:
- The ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures
- CD4+ count of ≥ 50 cells/μL
- Stable renal function: serum creatinine measurements to be taken at least once (within
three months of screening)
- Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without
change in medical management, for 3 months prior to baseline
- Normal electrocardiogram (ECG)
- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 x ULN
- Females of childbearing potential must agree to utilize highly effective contraception
methods (two separate forms of contraception, one of which must be an effective
barrier method, or be non-heterosexually active, practice sexual abstinence) from
screening throughout the duration of study treatment and for 30 days following the
last dose of study drug
- Females who utilize hormonal contraceptive as one of their birth control methods must
have used the same method for at least three months prior to study dosing
- Males must agree to utilize a highly effective method of contraception during
heterosexual intercourse throughout the study period and for 30 days following
discontinuation of investigational medicinal product. A highly effective method of
contraception is defined as two separate forms of contraception, one of which must be
an effective barrier method, or males must be non-heterosexually active, or practice
sexual abstinence
Key Exclusion Criteria:
- A new AIDS-defining condition (excluding CD4 cell count and percentage criteria)
diagnosed within the 30 days prior to screening,with the exception of the first two
bullet points
- Hepatitis C virus (HCV) antibody positive. Individuals who are HCV positive, but have
a documented negative HCV RNA, are eligible
- Hepatitis B surface antigen (HBVsAg) positive
- Individuals receiving drug treatment for Hepatitis C, or individuals who are
anticipated to receive treatment for Hepatitis C during the course of the study
- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
- Females who are breastfeeding
- Positive serum pregnancy test
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the Investigator to potentially interfere
with study compliance
- A history of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous
squamous carcinoma
- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline
- Individuals on hemodialysis, other forms of renal replacement therapy, or on treatment
for underlying kidney diseases (including prednisolone and dexamethasone)
- Individuals receiving ongoing therapy with any medications not to be used with EVG,
COBI, FTC, or TAF or individuals with any known allergies to the excipients of
E/C/F/TAF
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Debbie Slamowitz
(650) 723-2804
Not Recruiting
Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: E/C/F/TAF
Eligibility
Key Inclusion Criteria:
Cohort 1 (treatment-experienced switch)
- Must not have a history of known resistance to elvitegravir (EVG), tenofovir
disoproxil fumarate (TDF), or emtricitabine (FTC)
- Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels
(according to the local assay being used) in the 6 months preceding the screening
visit and have HIV-1 RNA < 50 copies/mL at screening
- Estimated glomerular filtration rate (GFR) 30-69 mL/min according to the
Cockcroft-Gault formula for creatinine clearance, using actual weight
- May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and
GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit for that
study is complete; or currently receiving Stribild® (STB) or atazanavir
(ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or
GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit for that
study is complete.
Cohort 2 (treatment-naive)
- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
- Screening genotype report provided by Gilead Sciences must show sensitivity to EVG,
FTC, and TDF
- No prior use of any approved or investigational antiretroviral drug for any length of
time, except the use for pre-exposure prophylaxis (PrEP), or post-exposure prophylaxis
(PEP), up to 6 months prior to screening
- Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine
clearance, using actual weight
All Cohorts:
All individuals must meet all of the following inclusion criteria to be eligible for
participation in this study:
- The ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures
- CD4+ count of ≥ 50 cells/μL
- Stable renal function: serum creatinine measurements to be taken at least once (within
three months of screening)
- Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without
change in medical management, for 3 months prior to baseline
- Normal electrocardiogram (ECG)
- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 x ULN
- Females of childbearing potential must agree to utilize highly effective contraception
methods (two separate forms of contraception, one of which must be an effective
barrier method, or be non-heterosexually active, practice sexual abstinence) from
screening throughout the duration of study treatment and for 30 days following the
last dose of study drug
- Females who utilize hormonal contraceptive as one of their birth control methods must
have used the same method for at least three months prior to study dosing
- Males must agree to utilize a highly effective method of contraception during
heterosexual intercourse throughout the study period and for 30 days following
discontinuation of investigational medicinal product. A highly effective method of
contraception is defined as two separate forms of contraception, one of which must be
an effective barrier method, or males must be non-heterosexually active, or practice
sexual abstinence
Key Exclusion Criteria:
- A new AIDS-defining condition (excluding CD4 cell count and percentage criteria)
diagnosed within the 30 days prior to screening,with the exception of the first two
bullet points
- Hepatitis C virus (HCV) antibody positive. Individuals who are HCV positive, but have
a documented negative HCV RNA, are eligible
- Hepatitis B surface antigen (HBVsAg) positive
- Individuals receiving drug treatment for Hepatitis C, or individuals who are
anticipated to receive treatment for Hepatitis C during the course of the study
- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
- Females who are breastfeeding
- Positive serum pregnancy test
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the Investigator to potentially interfere
with study compliance
- A history of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous
squamous carcinoma
- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline
- Individuals on hemodialysis, other forms of renal replacement therapy, or on treatment
for underlying kidney diseases (including prednisolone and dexamethasone)
- Individuals receiving ongoing therapy with any medications not to be used with EVG,
COBI, FTC, or TAF or individuals with any known allergies to the excipients of
E/C/F/TAF
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Debbie Slamowitz
(650) 723-2804
Not Recruiting
Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: E/C/F/TAF
Eligibility
Key Inclusion Criteria:
Cohort 1 (treatment-experienced switch)
- Must not have a history of known resistance to elvitegravir (EVG), tenofovir
disoproxil fumarate (TDF), or emtricitabine (FTC)
- Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels
(according to the local assay being used) in the 6 months preceding the screening
visit and have HIV-1 RNA < 50 copies/mL at screening
- Estimated glomerular filtration rate (GFR) 30-69 mL/min according to the
Cockcroft-Gault formula for creatinine clearance, using actual weight
- May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and
GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit for that
study is complete; or currently receiving Stribild® (STB) or atazanavir
(ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or
GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit for that
study is complete.
Cohort 2 (treatment-naive)
- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
- Screening genotype report provided by Gilead Sciences must show sensitivity to EVG,
FTC, and TDF
- No prior use of any approved or investigational antiretroviral drug for any length of
time, except the use for pre-exposure prophylaxis (PrEP), or post-exposure prophylaxis
(PEP), up to 6 months prior to screening
- Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine
clearance, using actual weight
All Cohorts:
All individuals must meet all of the following inclusion criteria to be eligible for
participation in this study:
- The ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures
- CD4+ count of ≥ 50 cells/μL
- Stable renal function: serum creatinine measurements to be taken at least once (within
three months of screening)
- Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without
change in medical management, for 3 months prior to baseline
- Normal electrocardiogram (ECG)
- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 x ULN
- Females of childbearing potential must agree to utilize highly effective contraception
methods (two separate forms of contraception, one of which must be an effective
barrier method, or be non-heterosexually active, practice sexual abstinence) from
screening throughout the duration of study treatment and for 30 days following the
last dose of study drug
- Females who utilize hormonal contraceptive as one of their birth control methods must
have used the same method for at least three months prior to study dosing
- Males must agree to utilize a highly effective method of contraception during
heterosexual intercourse throughout the study period and for 30 days following
discontinuation of investigational medicinal product. A highly effective method of
contraception is defined as two separate forms of contraception, one of which must be
an effective barrier method, or males must be non-heterosexually active, or practice
sexual abstinence
Key Exclusion Criteria:
- A new AIDS-defining condition (excluding CD4 cell count and percentage criteria)
diagnosed within the 30 days prior to screening,with the exception of the first two
bullet points
- Hepatitis C virus (HCV) antibody positive. Individuals who are HCV positive, but have
a documented negative HCV RNA, are eligible
- Hepatitis B surface antigen (HBVsAg) positive
- Individuals receiving drug treatment for Hepatitis C, or individuals who are
anticipated to receive treatment for Hepatitis C during the course of the study
- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
- Females who are breastfeeding
- Positive serum pregnancy test
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the Investigator to potentially interfere
with study compliance
- A history of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous
squamous carcinoma
- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline
- Individuals on hemodialysis, other forms of renal replacement therapy, or on treatment
for underlying kidney diseases (including prednisolone and dexamethasone)
- Individuals receiving ongoing therapy with any medications not to be used with EVG,
COBI, FTC, or TAF or individuals with any known allergies to the excipients of
E/C/F/TAF
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Debbie Slamowitz
(650) 723-2804
Not Recruiting
Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: E/C/F/TAF
Eligibility
Key Inclusion Criteria:
Cohort 1 (treatment-experienced switch)
- Must not have a history of known resistance to elvitegravir (EVG), tenofovir
disoproxil fumarate (TDF), or emtricitabine (FTC)
- Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels
(according to the local assay being used) in the 6 months preceding the screening
visit and have HIV-1 RNA < 50 copies/mL at screening
- Estimated glomerular filtration rate (GFR) 30-69 mL/min according to the
Cockcroft-Gault formula for creatinine clearance, using actual weight
- May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and
GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit for that
study is complete; or currently receiving Stribild® (STB) or atazanavir
(ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or
GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit for that
study is complete.
Cohort 2 (treatment-naive)
- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
- Screening genotype report provided by Gilead Sciences must show sensitivity to EVG,
FTC, and TDF
- No prior use of any approved or investigational antiretroviral drug for any length of
time, except the use for pre-exposure prophylaxis (PrEP), or post-exposure prophylaxis
(PEP), up to 6 months prior to screening
- Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine
clearance, using actual weight
All Cohorts:
All individuals must meet all of the following inclusion criteria to be eligible for
participation in this study:
- The ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures
- CD4+ count of ≥ 50 cells/μL
- Stable renal function: serum creatinine measurements to be taken at least once (within
three months of screening)
- Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without
change in medical management, for 3 months prior to baseline
- Normal electrocardiogram (ECG)
- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Adequate hematologic function
- Serum amylase ≤ 5 x ULN
- Females of childbearing potential must agree to utilize highly effective contraception
methods (two separate forms of contraception, one of which must be an effective
barrier method, or be non-heterosexually active, practice sexual abstinence) from
screening throughout the duration of study treatment and for 30 days following the
last dose of study drug
- Females who utilize hormonal contraceptive as one of their birth control methods must
have used the same method for at least three months prior to study dosing
- Males must agree to utilize a highly effective method of contraception during
heterosexual intercourse throughout the study period and for 30 days following
discontinuation of investigational medicinal product. A highly effective method of
contraception is defined as two separate forms of contraception, one of which must be
an effective barrier method, or males must be non-heterosexually active, or practice
sexual abstinence
Key Exclusion Criteria:
- A new AIDS-defining condition (excluding CD4 cell count and percentage criteria)
diagnosed within the 30 days prior to screening,with the exception of the first two
bullet points
- Hepatitis C virus (HCV) antibody positive. Individuals who are HCV positive, but have
a documented negative HCV RNA, are eligible
- Hepatitis B surface antigen (HBVsAg) positive
- Individuals receiving drug treatment for Hepatitis C, or individuals who are
anticipated to receive treatment for Hepatitis C during the course of the study
- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)
- Females who are breastfeeding
- Positive serum pregnancy test
- Have an implanted defibrillator or pacemaker
- Current alcohol or substance use judged by the Investigator to potentially interfere
with study compliance
- A history of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous
squamous carcinoma
- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline
- Individuals on hemodialysis, other forms of renal replacement therapy, or on treatment
for underlying kidney diseases (including prednisolone and dexamethasone)
- Individuals receiving ongoing therapy with any medications not to be used with EVG,
COBI, FTC, or TAF or individuals with any known allergies to the excipients of
E/C/F/TAF
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Debbie Slamowitz
(650) 723-2804
Not Recruiting