HIV-2 InfectionPhase 4Stribild HIV-2NCT02180438

An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal

A Phase 4 study testing Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks in people with HIV-2 Infection, run by University of Washington at 1 site in Senegal.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-2 Infection
What is being tested?: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSenegal
Study dates: Sep 2014to Jan 2017
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent
Age > 18 years old
HIV-2 Infection (confirmed by DetermineTM \& Immunocomb II)
ARV-naïve
CD4 count < 750 cells/mm3 and/or WHO Stage 3 or 4 disease
Anticipate residing in Dakar area for duration of study

Who cannot join

Pregnancy or Breast feeding
HIV-1 or HIV-1/HIV-2 dual infection
Known allergy or contraindication to Elvitegravir, Cobicistat, Emtricitabine, or Tenofovir DF
Active Tuberculosis (STRIBILD contraindicated with rifampin)

Trial locations and contacts

1 site in 1 country.

Senegal1 site

Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Dakar

Other trials in Senegal

About this study

Official title: An Open Label Trial of STRIBILD™ (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) for ARV-naïve HIV-2 Infected Adults in Dakar, Senegal

There is a critical need for safe and effective antiretroviral treatment (ART) regimens for HIV-2 infection. This is especially true in West Africa, where the vast majority of the 1-2 million individuals infected with HIV-2 live and were access to effective ART for HIV-2 is limited. HIV-2 is intrinsically resistant to non-nucleoside reverse transcriptase inhibitors (NNRTI) and the fusion inhibitor enfuvirtide (T-20) and mutations conferring broad resistance to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) are frequently observed in HIV-2 from patients receiving ART. Although antiretroviral protease inhibitors (PI) can be used effectively to treat HIV- 2, HIV-1 and HIV-2 also exhibit important differences in their susceptibilities with studies indicating that saquinavir (SQV), lopinavir (LPV), and darunavir (DRV) are the only potent PI's against HIV-2 replication and cross-resistance is frequent. Although an increasing body of evidence supports the potential utility of integrase inhibitors (INI) against HIV-2, there have been no clinical trials to assess their effectiveness and they are not routinely available in resource-limited settings. These limitations present major challenges to HIV-2 treatment, particularly in the areas in which it is most prevalent. This study is the 1st use of STRIBILD (elvitegravir (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir disoproxil fumarate (TDF)), an INI-based single tablet regimen, in HIV-2 infected adults in West Africa. The investigators hypothesize STRIBILD will be safe and effective as ART for HIV-2 infection. The Specific Aims of this study are: AIM 1: A pilot, open label, 48 week trial of STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) in 30 ARV-naïve HIV-2 Infected Adults in Dakar, Senegal. AIM 2: Determination of genotypic and phenotypic HIV-2 antiretroviral resistance in individuals with virologic failure (HIV-2 plasma RNA >250 copies/ml) participating in the 48 week trial of STRIBILD

Conditions: HIV-2 Infection
Being tested: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Keywords: HIV-2

What participants receive

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

Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeksDrug

Study groups in NCT02180438
Study group	Role	What they receive
Open label prospective single arm study of Stribild	Experimental	Not described Receives: Drug: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks

What is being measured

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

Death
Number of Participants Experiencing Death within the study period
Measured: 48 weeks
New WHO Stage 3 or 4 Event
New AIDS defining event per WHO criteria
Measured: 48 weeks
Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
Measured: 48 weeks

Secondary outcomes (5)

Grade 3 or 4 Adverse Events
Adverse event per NIH/DAIDS criteria
Measured: 48 weeks
CD4 T-cell Count at 48 Weeks < Baseline
Measured: 48 weeks
< 50 CD4 T-cell Increase at 48 Weeks From Baseline
Measured: 48 weeks
Switching Off Stribild Prior to 48 Weeks
Measured: 48 Weeks
Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF
Measured: 48 weeks

Timeline

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

Sep 2014Jan 2017

First posted2 Jul 2014 (estimated)
Study startSep 2014
Primary completionJan 2017
Study completionJan 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 HIV-2 InfectionStudies of the same condition, open and under way.
More trials run by University of WashingtonThe 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02180438
Sponsor's protocol ID: STUDY00000757
Acronym: Stribild HIV-2
Status last verified: Jun 2018
First submitted: 29 May 2014
Last updated: 26 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Ba S, Raugi DN, Smith RA, Sall F, Faye K, Hawes SE, Sow PS, Seydi M, Gottlieb GS; University of Washington-Dakar HIV-2 Study Group. A Trial of a Single-tablet Regimen of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate for the Initial Treatment of Human Immunodeficiency Virus Type 2 Infection in a Resource-limited Setting: 48-Week Results From Senegal, West Africa. Clin Infect Dis. 2018 Oct 30;67(10):1588-1594. doi: 10.1093/cid/ciy324.
PubMed 29672676

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Trial of STRIBILD™ (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) for ARV-naïve HIV-2 Infected Adults in Dakar, Senegal
ClinicalTrials.gov ID: NCT02180438
Acronym / sponsor ID: Stribild HIV-2 / STUDY00000757
Conditions: HIV-2 Infection
Keywords: HIV-2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann, Gilead Sciences
Study start: Sep 2014 (actual)
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 2 Jul 2014 (estimated)
Results: Posted 8 May 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open label prospective single arm study of Stribild	Experimental	Drug: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Written informed consent
Age > 18 years old
HIV-2 Infection (confirmed by DetermineTM \& Immunocomb II)
ARV-naïve
CD4 count < 750 cells/mm3 and/or WHO Stage 3 or 4 disease

Key exclusion criteria (4 listed)

Pregnancy or Breast feeding
HIV-1 or HIV-1/HIV-2 dual infection
Known allergy or contraindication to Elvitegravir, Cobicistat, Emtricitabine, or Tenofovir DF
Active Tuberculosis (STRIBILD contraindicated with rifampin)

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
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks	Drug	Open label prospective single arm study of Stribild

Primary outcome

Death
Time frame: 48 weeks
Number of Participants Experiencing Death within the study period
New WHO Stage 3 or 4 Event
Time frame: 48 weeks
New AIDS defining event per WHO criteria
Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
Time frame: 48 weeks

5 secondary outcomes

Grade 3 or 4 Adverse Events
Time frame: 48 weeks
CD4 T-cell Count at 48 Weeks < Baseline
Time frame: 48 weeks
< 50 CD4 T-cell Increase at 48 Weeks From Baseline
Time frame: 48 weeks
Switching Off Stribild Prior to 48 Weeks
Time frame: 48 Weeks
Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF
Time frame: 48 weeks

Results and safety

Results posted to the registry on 8 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label Prospective Single Arm Study of Stribild	30	29

Primary outcome: Death

Time frame: 48 weeks. Count of participants. Unit: Participants

Measure	Open Label Prospective Single Arm Study of Stribild n = 30
Value	0

Primary outcome: New WHO Stage 3 or 4 Event

Time frame: 48 weeks. Count of participants. Unit: Participants

Measure	Open Label Prospective Single Arm Study of Stribild n = 30
Value	0

Primary outcome: Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)

Time frame: 48 weeks. Count of participants. Unit: Participants

Measure	Open Label Prospective Single Arm Study of Stribild n = 30
>50 copies/mL	1
>400 copies/mL	0

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label Prospective Single Arm Study of Stribild	1 of 30 (3.3%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29672676Ba S, Raugi DN, Smith RA, Sall F, Faye K, Hawes SE, Sow PS, Seydi M, Gottlieb GS; University of Washington-Dakar HIV-2 Study Group. A Trial of a Single-tablet Regimen of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate for the Initial Treatment of Human Immunodeficiency Virus Type 2 Infection in a Resource-limited Setting: 48-Week Results From Senegal, West Africa. Clin Infect Dis. 2018 Oct 30;67(10):1588-1594. doi: 10.1093/cid/ciy324.

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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.

Geoffrey S Gottlieb, MD PhD principal investigator

University of Washington

Moussa Seydi, MD principal investigator

Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks in people with HIV-2 Infection, run by University of Washington at 1 site in Senegal.

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 6 inclusion and 4 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 26 Jul 2018. 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 Senegal. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2018). 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?

Death (time frame: 48 weeks). The study lists 3 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 NCT02180438, 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 26 Jul 2018.