Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02251236
Recruitment Status : Completed
First Posted : September 29, 2014
Results First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Collaborators:
Gilead Sciences
University at Buffalo
Information provided by (Responsible Party):
Scott Letendre, University of California, San Diego

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The project will have two tracks, one for participants who are currently taking elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track B).

Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF) STR** (if available) for 24 weeks.

*Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate.

**Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide fumarate.


Condition or disease Intervention/treatment Phase
HIV Drug: Stribild Drug: Genvoya Not Applicable

Detailed Description:
The proposed project will be a prospective, open-label treatment trial of 14 HIV-infected adults. Participants will be enrolled in two tracks. Track A will enroll participants who have been taking E/C/F/TDF to E/C/F/TAF for at least 12 weeks. Track B will enroll participants who are not taking ART and no prior exposure to elvitegravir and no genotypic drug resistance to any component of E/C/F/TDF to E/C/F/TAF. CSF and blood will be collected twice in Track A (two on-treatment assessments) and three times in Track B (one pre-treatment, two on-treatment assessments). If possible, we plan to time assessments to bridge the transition from E/C/F/TDF to E/C/F/TAF so that all participants will ideally have one CSF collection on each regimen, enabling a paired comparison of tenofovir concentrations between the two tenofovir formulations. We estimate that 28 on-treatment CSF collections will be sufficient to provide a small-sample estimate of the distribution of elvitegravir, tenofovir and TAF into CSF.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals
Study Start Date : January 2016
Actual Primary Completion Date : January 18, 2017
Actual Study Completion Date : January 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Stribild Arm
Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.
 Drug: Stribild
To be administered orally, once daily with food.
Other Name: Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate

Drug: Genvoya
To be administered orally, once daily with food.
Other Name: Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide
Genvoya Arm
Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.
 Drug: Genvoya
To be administered orally, once daily with food.
Other Name: Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide
Untreated Arm
Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.
 Drug: Stribild
To be administered orally, once daily with food.
Other Name: Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate

Drug: Genvoya
To be administered orally, once daily with food.
Other Name: Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline [ Time Frame: Baseline ]
  2. Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24 [ Time Frame: Week 24 ]
  3. Concentration of Tenofovir in Cerebrospinal Fluid at Baseline [ Time Frame: Baseline ]
  4. Concentration of Tenofovir in Cerebrospinal Fluid at Week 24 [ Time Frame: Week 24 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult men or women aged 18-60 years. Able and willing to provide informed consent.
  • Presence of HIV-1 infection as documented by a licensed ELISA test kit and confirmed by Western blot or HIV RNA.
  • Track A (Currently taking E/C/F/TDF or E/C/F/TAF): Taking E/C/F/TDF or E/C/F/TAF for at least 3 months prior to screening and undetectable plasma HIV-1 RNA (≤ 40 copies/mL)
  • Track B (Currently not taking ART): Off ART for at least 3 months. Prior exposure to TDF and FTC will be allowed but subjects must not have primary genotypic drug resistance mutations to elvitegravir, tenofovir, or emtricitabine (see Exclusion Criteria)
  • Plasma HIV-1 RNA ≥ 5,000c/mL and CD4+ T-cell count ≥200cells/mm3.

Exclusion Criteria:

  • Track B: Presence of primary drug resistance mutations for EVG, tenofovir, or emtricitabine.
  • Use of drugs of abuse or alcohol which would interfere with adherence or completion of this study. While on-study, subjects will be instructed not to consume alcohol for 48 hours prior to pharmacokinetic sampling days.
  • Pregnancy or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to study entry and day of entry.
  • Chronic, severe, or other medical conditions that, in the opinion of the investigator, would interfere with the subjects ability to participate in the protocol.
  • Use of prohibited protocol-specified drugs, prescription or over-the-counter, within 14 days prior to study entry.
  • Bleeding abnormality or other contraindication to lumbar puncture.
  • Moderate or severe cognitive impairment by history or based on Montreal Cognitive Assessment.
  • Hepatitis B surface antigen (HBsAg) positive (Positive anti-HBs antibody and negative HBsAg results are acceptable)
  • Hepatitis C antibody (HCV Ab) positive

  • Laboratory parameters documented within 21 days prior to study entry that would increase the risk for adverse events:

    1. Hemoglobin < 12.5 g/dL for men; < 11.5 g/dL for women;
    2. Platelet count < 100,000 platelets/mm3;
    3. AST (SGOT) or ALT (SGPT) > 1.5 x the upper limit of normal (ULN);
    4. Estimated GFR<70 ml/min
    5. Weight less than 50 kg
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02251236


Locations
Layout table for location information
United States, California
UC San Diego AntiViral Research Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Gilead Sciences
University at Buffalo
Investigators
Layout table for investigator information
Principal Investigator: Scott Letendre, MD UCSD
  Study Documents (Full-Text)

Documents provided by Scott Letendre, University of California, San Diego:
Study Protocol and Statistical Analysis Plan  [PDF] July 2, 2014

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Scott Letendre, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02251236     History of Changes
Other Study ID Numbers: IN-US-236-1266
First Posted: September 29, 2014    Key Record Dates
Results First Posted: October 31, 2019
Last Update Posted: October 31, 2019
Last Verified: October 2019
Keywords provided by Scott Letendre, University of California, San Diego:
Stribild
Genvoya
elvitegravir
Cerebrospinal Fluid
HIV
Additional relevant MeSH terms:
Layout table for MeSH terms
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Genvoya
Antiviral Agents
Anti-Infective Agents
 Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors