Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006518

Trial Description

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Title

A Phase 3 Open-label Safety Study of Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study is to characterize the effect of Cobicistat based regimens on parameters of renal
function in HIV infected patients with mild to moderate renal impairment, and also, to
assess the safety and tolerability of those regimens in order to generate appropriate dosing
recommendations.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006518
  •   2015/03/13
  •   2011/05/11
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01363011  (ClinicalTrials.gov)
  •   GS-US-236-0118  (Gilead Sciences)
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Health Condition or Problem studied

  •   Acquired Immunodeficiency Syndrome
  •   HIV Infections
  •   B20-B24 -  Human immunodeficiency virus [HIV] disease
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Interventions/Observational Groups

  •   Drug: EVG/COBI/FTC/TDF
  •   Drug: COBI
  •   Drug: ATV
  •   Drug: DRV
  •   Drug: NRTI
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Change from baseline in estimated glomerular filtration rate; time frame: Baseline to Week 24

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Secondary Outcome

- Proportion of participants achieving virologic response (HIV-1 RNA < 50 copies/mL); time frame: Weeks 24, 48 and 96
- Long term effect of COBI-containing regimens on renal parameters; time frame: Weeks 24, 48, and 96; Safety data regarding renal parameters will be summarized.
- Incidence of adverse events and graded laboratory abnormalities; time frame: Baseline to Week 96 plus 30 days; All safety data will be summarized by treatment group.
- Plasma pharmacokinetics (PK) parameters of COBI as measured by Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau, and T½.; time frame: Baseline, Weeks, 2, 4, and 24; Cmax is defined as the maximum observed concentration of drug in plasma
Tmax is defined as the time of Cmax
Clast is defined as the last observable concentration of drug
Tlast is defined as the time of Clast
Ctau is defined as the observed drug concentration at the end of the dosing interval
λz is defined as the terminal elimination rate constant
AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)
t1/2 is defined as the estimate of the terminal elimination half-life of the drug

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Canada
  •   Dominican Republic
  •   Germany
  •   Mexico
  •   Puerto Rico
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/05/31
  •   100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Cohort 1 (Treatment Naïve)

- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

- Screening genotype report must show sensitivity to FTC and TDF

- No prior use of any approved or investigational antiretroviral drug for any length of
time

Cohort 2 (Pharmacoenhancer Switch)

- Subjects must be receiving atazanavir (ATV) 300 mg/ritonavir (RTV) 100 mg plus 2
NRTIs OR darunavir (DRV) 800 mg/RTV 100 mg plus 2 NRTIs for at least 6 months prior
to screening

- Plasma HIV-1 RNA concentrations at undetectable levels in the 6 months preceding the
screening visit and have HIV-1 RNA < 50 copies/mL at screening

- Subjects experiencing intolerance to RTV (as determined by the Investigator)

Cohort 1 and Cohort 2

- The ability to understand and sign a written informed consent form

- Normal ECG

- Mild to Moderate renal function

- Stable renal function

- Hepatic transaminases (AST and ALT) ≤ 5 x the upper limit of the normal range (ULN)

- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin (subjects with documented
Gilbert's Syndrome or hyperbilirubinemia due to atazanavir therapy may have total
bilirubin up to 5 x upper limit of normal)

- Adequate hematologic function

- Serum amylase ≤ 5 x ULN

- Males and females of childbearing potential must agree to utilize highly effective
contraception methods from screening throughout the duration of study treatment and
for 30 days following the last dose of study drug

- Age ≥ 18 years

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Exclusion Criteria

- New AIDS defining condition diagnosed within the 30 days prior to screening

- Receiving drug treatment for Hepatitis C, or anticipated to receive treatment for
Hepatitis C

- Subjects experiencing decompensated cirrhosis

- Females who are breastfeeding

- Positive serum pregnancy test (female of childbearing potential)

- Implanted defibrillator or pacemaker

- Current alcohol or substance use judged by the Investigator to potentially interfere
with subject study compliance

- 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

- Receiving ongoing therapy with any of medications contraindicated for use with EVG,
COBI, FTC, TDF, ATV, DRV; or subjects with any known allergies to the excipients of
EVG/COBI/FTC/TDF STR, COBI tablets, atazanavir capsules or darunavir tablets or
contraindicated for the 2 NRTIs as part of the Cohort 2 regimen

- Participation in any other clinical trial without prior approval

- Any other clinical condition or prior therapy that would make the subject unsuitable
for the study or unable to comply with the dosing requirements

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Addresses

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    • Gilead Sciences
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    • Gilead Sciences
    • Javier Szwarcberg, MD 
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    • Gilead Sciences
    • Javier Szwarcberg, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.