Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals
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ClinicalTrials.gov Identifier: NCT02251236 |
Recruitment Status :
Completed
First Posted : September 29, 2014
Results First Posted : October 31, 2019
Last Update Posted : October 31, 2019
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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 |
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HIV | Drug: Stribild Drug: Genvoya | Not Applicable |
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 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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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 |
- Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline [ Time Frame: Baseline ]
- Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24 [ Time Frame: Week 24 ]
- Concentration of Tenofovir in Cerebrospinal Fluid at Baseline [ Time Frame: Baseline ]
- Concentration of Tenofovir in Cerebrospinal Fluid at Week 24 [ Time Frame: Week 24 ]

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.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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Laboratory parameters documented within 21 days prior to study entry that would increase the risk for adverse events:
- Hemoglobin < 12.5 g/dL for men; < 11.5 g/dL for women;
- Platelet count < 100,000 platelets/mm3;
- AST (SGOT) or ALT (SGPT) > 1.5 x the upper limit of normal (ULN);
- Estimated GFR<70 ml/min
- Weight less than 50 kg

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
United States, California | |
UC San Diego AntiViral Research Center | |
San Diego, California, United States, 92103 |
Principal Investigator: | Scott Letendre, MD | UCSD |
Documents provided by Scott Letendre, University of California, San Diego:
Responsible Party: | Scott Letendre, Associate Professor of Medicine, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT02251236 |
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 |
Stribild Genvoya elvitegravir Cerebrospinal Fluid HIV |
Tenofovir Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Cobicistat Emtricitabine tenofovir alafenamide Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Elvitegravir Antiviral Agents Anti-Infective Agents |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Integrase Inhibitors |