HIVNCT02251236

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

A study testing Stribild and Genvoya in people with HIV, run by University of California, San Diego at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: HIV
What is being tested?: Stribild and Genvoya
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Jan 2016to 18 Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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:
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

Trial locations and contacts

1 site in 1 country.

United States1 site

UC San Diego AntiViral Research Center
San Diego, California, 92103

Other trials in United States

About this study

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.

Read the 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.

Conditions: HIV
Being tested: Stribild, Genvoya
Keywords: Stribild, Genvoya, elvitegravir, Cerebrospinal Fluid, HIV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

StribildDrug
Also called Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate
To be administered orally, once daily with food.
GenvoyaDrug
Also called Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide
To be administered orally, once daily with food.

Study groups in NCT02251236
Study group	Role	What they receive
Stribild Arm	Other	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. Receives: Drug: Stribild; Drug: Genvoya
Genvoya Arm	Other	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. Receives: Drug: Genvoya
Untreated Arm	Other	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. Receives: Drug: Stribild; Drug: Genvoya

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline
Measured: Baseline
Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24
Measured: Week 24
Concentration of Tenofovir in Cerebrospinal Fluid at Baseline
Measured: Baseline
Concentration of Tenofovir in Cerebrospinal Fluid at Week 24
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201618 Jan 2017

First posted29 Sep 2014 (estimated)
Study startJan 2016
Primary completion18 Jan 2017
Study completion18 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by University of California, San DiegoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02251236
Sponsor's protocol ID: IN-US-236-1266
Status last verified: Oct 2019
First submitted: 24 Sep 2014
Last updated: 31 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ma Q, Ocque AJ, Morse GD, Sanders C, Burgi A, Little SJ, Letendre SL. Switching to Tenofovir Alafenamide in Elvitegravir-Based Regimens: Pharmacokinetics and Antiviral Activity in Cerebrospinal Fluid. Clin Infect Dis. 2020 Aug 14;71(4):982-988. doi: 10.1093/cid/ciz926.
PubMed 31560741

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals
ClinicalTrials.gov ID: NCT02251236
Acronym / sponsor ID: IN-US-236-1266
Conditions: HIV
Keywords: Stribild, Genvoya, elvitegravir, Cerebrospinal Fluid, HIV
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Collaborators: Gilead Sciences, University at Buffalo
Study start: Jan 2016
Primary completion: 18 Jan 2017 (actual)
Study completion: 18 Jan 2017 (actual)
First posted: 29 Sep 2014 (estimated)
Results: Posted 31 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Stribild Arm	Other	Drug: Stribild, Drug: GenvoyaStribild 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.
Genvoya Arm	Other	Drug: GenvoyaGenvoya 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.
Untreated Arm	Other	Drug: Stribild, Drug: GenvoyaUntreated 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
StribildAlso: Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarateTo be administered orally, once daily with food.	Drug	Stribild Arm, Untreated Arm
GenvoyaAlso: Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamideTo be administered orally, once daily with food.	Drug	Genvoya Arm, Stribild Arm, Untreated Arm

Primary outcome

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

Results and safety

Results posted to the registry on 31 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stribild Arm	9	9
Genvoya Arm	5	5
Untreated Arm	0	0

Primary outcome: Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline

Time frame: Baseline. Median (Full Range). Unit: ng/mL

Measure	Stribild Arm n = 9	Genvoya Arm n = 5	Untreated Arm n = 0
Value	4.3 (3.11 to 5.20)	2.72 (1.75 to 3.48)	–

Population analysed: No participants enrolled in the Untreated Arm

Primary outcome: Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24

Time frame: Week 24. Median (Full Range). Unit: ng/mL

Measure	Stribild Arm n = 9	Genvoya Arm n = 5	Untreated Arm n = 0
Value	5.90 (4.44 to 6.60)	3.09 (3.02 to 3.62)	–

Population analysed: No participants enrolled in the Untreated Arm

Primary outcome: Concentration of Tenofovir in Cerebrospinal Fluid at Baseline

Time frame: Baseline. Median (Full Range). Unit: ng/mL

Measure	Stribild Arm n = 9	Genvoya Arm n = 5	Untreated Arm n = 0
Value	3.03 (2.13 to 4.84)	0.49 (0.35 to 0.67)	–

Population analysed: No participants enrolled in the Untreated Arm

Primary outcome: Concentration of Tenofovir in Cerebrospinal Fluid at Week 24

Time frame: Week 24. Median (Full Range). Unit: ng/mL

Measure	Stribild Arm n = 9	Genvoya Arm n = 5	Untreated Arm n = 0
Value	0.507 (0.344 to 1.197)	0.481 (0.255 to 0.556)	–

Population analysed: No participants enrolled in the Untreated Arm

Adverse events

Time frame: 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stribild Arm	1 of 9 (11.1%)	4 of 9 (44.4%)	0 of 9
Genvoya Arm	1 of 5 (20%)	5 of 5 (100%)	0 of 5
Untreated Arm	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31560741Ma Q, Ocque AJ, Morse GD, Sanders C, Burgi A, Little SJ, Letendre SL. Switching to Tenofovir Alafenamide in Elvitegravir-Based Regimens: Pharmacokinetics and Antiviral Activity in Cerebrospinal Fluid. Clin Infect Dis. 2020 Aug 14;71(4):982-988. doi: 10.1093/cid/ciz926.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott Letendre, MD principal investigator

UCSD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Stribild and Genvoya in people with HIV, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02251236, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.