HIV-1 InfectionPhase 2NCT01286740

Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR

A Phase 2 study testing FTC/RPV/TDF in people with HIV-1 Infection, run by Gilead Sciences at 18 sites 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

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1 Infection
What is being tested?: FTC/RPV/TDF
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 18 sitesUnited States
Study dates: Jan 2011to Mar 2012
Phase: Phase 2
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

Ability to understand and sign a written informed consent form
Receiving EFV/FTC/TDF continuously for ≥ 3 months preceding the screening visit
Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for ≥ 8 weeks prior to the screening visit and HIV-1 RNA < 50 copies/mL at the screening visit
On their first antiretroviral drug regimen, and no HIV-1 RNA > 50 copies/mL measured at two consecutive time points after first achieving HIV RNA < 50 copies/mL
Had a genotype prior to starting FTC/RPV/TDF and no known resistance to any of the study agents
Normal ECG

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Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥ 50,000/mm^3; hemoglobin ≥ 8.5 g/dL)
Serum amylase ≤ 5 x ULN (subjects with serum amylase > 5 x ULN eligible if serum lipase ≤ 5 x ULN)
Adequate renal function (estimated glomerular filtration rate ≥ 50 mL/min according to the Cockcroft-Gault formula)
Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be nonheterosexually active, practice sexual abstinence, or have a vasectomized partner) from screening throughout the duration of the study period and for 60 days following the last dose of study drug.
Age ≥ 18 years
Life expectancy ≥ 1 year

Who cannot join

A new AIDS-defining condition diagnosed within 21 days prior to screening
Females who were breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Proven or suspected acute hepatitis in the 21 days prior to study entry
Subjects receiving drug treatment for Hepatitis C, or subjects anticipated to receive treatment for Hepatitis C during the course of the study, or with a history of liver disease
Was experiencing decompensated cirrhosis

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Implanted defibrillator or pacemaker
Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance
History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
Active, serious infections requiring parenteral antibiotic or antifungal therapy within 21 days prior to Baseline
All investigational drugs
Ongoing therapy or anticipated need to initiate drugs or herbal/natural supplements during the study that were contraindicated or not recommended for use as indicated in the protocol, including drugs not to be used with FTC, RPV, and TDF; or subjects with known allergies to the excipients of the FTC/RPV/TDF STR
Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial
Treatment with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Southwest Infectious Disease Clinical Research, Inc.
Addison, Texas, 75001
Atlanta ID Group
Atlanta, Georgia, 30309
Central Texas Clinical Research
Austin, Texas, 78705
Be Well Medical Center, P.C.
Berkley, Michigan, 48072
Community Research Initiative of New England
Boston, Massachusetts, 02215
Northstar Medical Center
Chicago, Illinois, 60657
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
Living Hope Clinical Foundation
Long Beach, California, 90814
Peter J. Ruane MD Inc
Los Angeles, California, 90036
Anthony Mills MD, Inc.
Los Angeles, California, 90069
The Kinder Medical Group
Miami, Florida, 33133
Orlando Immunology Center
Orlando, Florida, 32803
La Playa Medical Group and Clinical Research
San Diego, California, 92103
Peter Shalit, M.D.
Seattle, Washington, 98104
Southampton Healthcare, Inc.
St Louis, Missouri, 63139
Dupont Circle Physicians Group, P.C.
Washington D.C., District of Columbia, 20009
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
Capital Medical Associates, PC
Washington D.C., District of Columbia, 20036

Other trials in United States

About this study

Official title: A Phase 2B Open Label Pilot Study to Evaluate Switching From a Regimen Consisting of a Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Single Tablet Regimen (STR) to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) STR in Virologically Suppressed, HIV 1 Infected Subjects

The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA < 50 copies/mL at Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months prior to study start, were experiencing safety or tolerability concerns (in particular, EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.

Conditions: HIV-1 Infection
Being tested: FTC/RPV/TDF
Keywords: HIV-1, HIV, Treatment Experienced

What participants receive

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

FTC/RPV/TDFDrug
Also called Complera, Eviplera
Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily

Study groups in NCT01286740
Study group	Role	What they receive
FTC/RPV/TDF	Experimental	Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR. Receives: Drug: FTC/RPV/TDF

What is being measured

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

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.
Measured: Week 12

Secondary outcomes (12)

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
Measured: Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.
Measured: Week 48
Plasma Concentration of RPV and EFV at Week 1
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.
Measured: Week 1
Plasma Concentration of RPV and EFV at Week 2
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.
Measured: Week 2
Plasma Concentration of RPV and EFV at Week 4
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.
Measured: Week 4
Plasma Concentration of RPV and EFV at Week 6
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.
Measured: Week 6
Plasma Concentration of RPV and EFV at Week 8
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.
Measured: Week 8
Plasma Concentration of RPV at Week 12
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.
Measured: Week 12
Plasma Concentration of EFV at Week 12
The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12
Measured: Week 12
Plasma Concentration of RPV at Week 24
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.
Measured: Week 24
Plasma Concentration of RPV at Week 36
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.
Measured: Week 36
Plasma Concentration of RPV at Week 48
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.
Measured: Week 48

Timeline

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

Jan 2011Mar 2012

First posted31 Jan 2011 (estimated)
Study startJan 2011
Primary completionJul 2011
Study completionMar 2012

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.
Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01286740
Sponsor's protocol ID: GS-US-264-0111
Status last verified: Apr 2013
First submitted: 27 Jan 2011
Last updated: 26 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
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All HIV-1 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2B Open Label Pilot Study to Evaluate Switching From a Regimen Consisting of a Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Single Tablet Regimen (STR) to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) STR in Virologically Suppressed, HIV 1 Infected Subjects
ClinicalTrials.gov ID: NCT01286740
Acronym / sponsor ID: GS-US-264-0111
Conditions: HIV-1 Infection
Keywords: HIV-1, HIV, Treatment Experienced
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Jul 2011 (actual)
Study completion: Mar 2012 (actual)
First posted: 31 Jan 2011 (estimated)
Results: Posted 19 Apr 2013

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FTC/RPV/TDF	Experimental	Drug: FTC/RPV/TDFParticipants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.

Who may qualify

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

Key inclusion criteria (14 listed)

Ability to understand and sign a written informed consent form
Receiving EFV/FTC/TDF continuously for ≥ 3 months preceding the screening visit
Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels for ≥ 8 weeks prior to the screening visit and HIV-1 RNA < 50 copies/mL at the screening visit
On their first antiretroviral drug regimen, and no HIV-1 RNA > 50 copies/mL measured at two consecutive time points after first achieving HIV RNA < 50 copies/mL
Had a genotype prior to starting FTC/RPV/TDF and no known resistance to any of the study agents

Key exclusion criteria (15 listed)

A new AIDS-defining condition diagnosed within 21 days prior to screening
Females who were breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Proven or suspected acute hepatitis in the 21 days prior to study entry
Subjects receiving drug treatment for Hepatitis C, or subjects anticipated to receive treatment for Hepatitis C during the course of the study, or with a history of liver disease

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
FTC/RPV/TDFAlso: Complera, EvipleraEmtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily	Drug	FTC/RPV/TDF

Primary outcome

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)
Time frame: Week 12
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.

12 secondary outcomes

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)
Time frame: Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)
Time frame: Week 48
Plasma Concentration of RPV and EFV at Week 1
Time frame: Week 1
Plasma Concentration of RPV and EFV at Week 2
Time frame: Week 2
Plasma Concentration of RPV and EFV at Week 4
Time frame: Week 4
Plasma Concentration of RPV and EFV at Week 6
Time frame: Week 6
Plasma Concentration of RPV and EFV at Week 8
Time frame: Week 8
Plasma Concentration of RPV at Week 12
Time frame: Week 12
Plasma Concentration of EFV at Week 12
Time frame: Week 12
Plasma Concentration of RPV at Week 24
Time frame: Week 24
Plasma Concentration of RPV at Week 36
Time frame: Week 36
Plasma Concentration of RPV at Week 48
Time frame: Week 48

Results and safety

Results posted to the registry on 19 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FTC/RPV/TDF	50	48

Primary outcome: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)

Time frame: Week 12. Number. Unit: percentage of participants

Measure	FTC/RPV/TDF n = 49
Value	100

Population analysed: Full Analysis Set: participants who were enrolled into the study, received at least one dose of study drug and had no major protocol violation

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to Week 48. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FTC/RPV/TDF	1 of 49 (2%)	32 of 49 (65.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for HIV-1 Infection

Active, not recruitingPhase 1/2
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
HIV-1-infection
Recruiting
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
HIV1 Infection, HIV 2 Infection
Active, not recruitingObservational study
Investigating the Optimal Management of Dolutegravir Resistance
HIV-1-infection
RecruitingPhase 2/3
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
RecruitingPhase 2
Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption
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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.

David Pugatch, MD study director

Gilead Sciences

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FTC/RPV/TDF in people with HIV-1 Infection, run by Gilead Sciences at 18 sites 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 14 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 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 19 Apr 2013). 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?

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis) (time frame: Week 12). 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 NCT01286740.

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 Apr 2013.