HIVPhase 2NCT00869557

Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

A Phase 2 study testing Stribild and Atripla in people with HIV and HIV Infections, run by Gilead Sciences at 30 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, HIV Infections
What is being tested?: Stribild and Atripla
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 30 sitesUnited States
Study dates: Apr 2009to Sep 2013
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

Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
No prior use of any approved or experimental anti-HIV drug
Normal electrocardiogram (ECG)
Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula
Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

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Adequate hematologic function
Cluster determinant 4 (CD4) cell count > 50 cells/µL
Serum amylase ≤ 1.5 x ULN
Normal thyroid-stimulating hormone
Negative serum pregnancy test (for females of childbearing potential only)
Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drugs
Life expectancy ≥ 1 year
Ability to understand and sign a written informed consent form

Who cannot join

New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor resistance mutation(s)
Hepatitis B surface antigen positive
Hepatitis C antibody positive
Participants experiencing cirrhosis
Participants experiencing ascites

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Participants experiencing encephalopathy
Females who are breastfeeding
Positive serum pregnancy test (for females of childbearing potential)
Vaccinated within 90 days of study dosing
History or family history of Long QT Syndrome or family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30
Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
Prolonged QTcF interval at screening
PR interval ≥ 200 msec or ≤ 120 msec on ECG at screening
QRS ≥ 120 msec on ECG at screening
Implanted defibrillator or pacemaker
Participants receiving ongoing therapy with any disallowed medications
Current alcohol or substance use judged to potentially interfere with participant study compliance
History of or ongoing malignancy (including untreated carcinoma in situ) other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
Participation in any other clinical trial without prior approval
Medications contraindicated for use with EFV, EVG, COBI, FTC, or TDF
Any known allergies to the excipients of Atripla or Stribild tablets
Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

Chase Brexton Health Services, Inc.
Baltimore, Maryland, 21201
Be Well Medical Center
Berkley, Michigan, 48072
Community Research Initiative of New England
Boston, Massachusetts, 02215
Northstar Medical Center
Chicago, Illinois, 60657
Nicholaos Bellos, MD, PA
Dallas, Texas, 75204
AIDS Arms/ Peabody Health Center
Dallas, Texas, 75215
Infectious Disease Specialists of Atlanta (IDSA)
Decatur, Georgia, 30033
Apex Research Institute
Denver, Colorado, 80220
Broward Health
Fort Lauderdale, Florida, 33311
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, 33316
Gordon E. Crofoot, MD, PA
Houston, Texas, 77098
Rosedale Infectious Diseases
Huntersville, North Carolina, 28078
Health for Life Clinic, PLLC
Little Rock, Arkansas, 72207
The Living Hope Foundation
Long Beach, California, 90813
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036
Wohlfeiler, Piperato and Associates, LLC
Miami Beach, Florida, 33139
Chelsea Village Medical
New York, New York, 10011
Ricky K. Hsu, MD, PC
New York, New York, 10011
Orange Coast Medical Group
Newport Beach, California, 92663
East Bay AIDS Center
Oakland, California, 94609
Orlando Immunology Center
Orlando, Florida, 32803
Infectious Disease of Central Florida
Orlando, Florida, 32806
Metropolis Medical
San Francisco, California, 94115
Southwest C.A.R.E. Center
Santa Fe, New Mexico, 87505
TribalMed
Seattle, Washington, 98103
Southampton Healthcare, Inc.
St Louis, Missouri, 63139
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
Dupont Circle Physicians Group
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 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Atripla® (Efavirenz 600 mg/Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs.

Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).

Conditions: HIV, HIV Infections
Being tested: Stribild, Atripla
Keywords: HIV, HIV-1, Antiretroviral Treatment-Naive, treatment naive
Medical subject headings: HIV Infections

What participants receive

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

StribildDrug
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily (QD) + placebo to match Atripla once daily prior to bedtime (QHS)
AtriplaDrug
Atripla (EFV 150 mg/FTC 200mg/TDF 300 mg) STR QHS + placebo to match Stribild QD

Study groups in NCT00869557
Study group	Role	What they receive
Stribild	Experimental	Not described Receives: Drug: Stribild
Atripla	Active comparator	Not described Receives: Drug: Atripla

What is being measured

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

The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized.
Measured: Week 24

Secondary outcomes (5)

The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48
The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 48 was summarized.
Measured: Week 48
Change From Baseline in HIV-1 RNA (log_10 Copies/mL)
Change = Week 24 or 48 value minus baseline value
Measured: Baseline to Weeks 24 and 48
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24
Change = Week 24 value minus baseline value
Measured: Baseline to Week 24
Change From Baseline in CD4 Cell Count at Week 48
Change = Week 48 value minus baseline value
Measured: Baseline to Week 48
The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL
The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.
Measured: Baseline to Weeks 24 and 48

Timeline

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

Apr 2009Sep 2013

First posted26 Mar 2009 (estimated)
Study startApr 2009
Primary completionNov 2009
Study completionSep 2013

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 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00869557
Sponsor's protocol ID: GS-US-236-0104
Status last verified: May 2014
First submitted: 24 Mar 2009
Last updated: 4 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cohen C, Elion R, Ruane P, Shamblaw D, DeJesus E, Rashbaum B, Chuck SL, Yale K, Liu HC, Warren DR, Ramanathan S, Kearney BP. Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. AIDS. 2011 Mar 27;25(6):F7-12. doi: 10.1097/QAD.0b013e328345766f.
PubMed 21412057

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 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Atripla® (Efavirenz 600 mg/Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
ClinicalTrials.gov ID: NCT00869557
Acronym / sponsor ID: GS-US-236-0104
Conditions: HIV, HIV Infections
Keywords: HIV, HIV-1, Antiretroviral Treatment-Naive, treatment naive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Nov 2009 (actual)
Study completion: Sep 2013 (actual)
First posted: 26 Mar 2009 (estimated)
Results: Posted 22 Oct 2012

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Stribild	Experimental	Drug: Stribild
Atripla	Active comparator	Drug: Atripla

Who may qualify

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

Key inclusion criteria (14 listed)

Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
No prior use of any approved or experimental anti-HIV drug
Normal electrocardiogram (ECG)
Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula
Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)

Key exclusion criteria (24 listed)

New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor resistance mutation(s)
Hepatitis B surface antigen positive
Hepatitis C antibody positive
Participants experiencing cirrhosis

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
StribildStribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily (QD) + placebo to match Atripla once daily prior to bedtime (QHS)	Drug	Stribild
AtriplaAtripla (EFV 150 mg/FTC 200mg/TDF 300 mg) STR QHS + placebo to match Stribild QD	Drug	Atripla

Primary outcome

The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
Time frame: Week 24
The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized.

5 secondary outcomes

The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48
Time frame: Week 48
Change From Baseline in HIV-1 RNA (log_10 Copies/mL)
Time frame: Baseline to Weeks 24 and 48
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24
Time frame: Baseline to Week 24
Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline to Week 48
The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL
Time frame: Baseline to Weeks 24 and 48

Results and safety

Results posted to the registry on 22 Oct 2012, 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	48	45
Atripla	23	21

Primary outcome: The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24

Time frame: Week 24. Number. Unit: percentage of participants

Measure	Stribild n = 48	Atripla n = 23
Value	89.6	87.0

Stribild vs Atripla: Difference in the response rates (%): 2.8 (95% CI -14.5 to 20.1)

Population analysed: ITT analysis set (all participants who were randomized into the study and received at least 1 dose of study drug). The missing = failure (M = F) analysis method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stribild	2 of 48 (4.2%)	39 of 48 (81.3%)	Not reported
Atripla	1 of 23 (4.3%)	20 of 23 (87%)	Not reported
All Stribild	9 of 62 (14.5%)	57 of 62 (91.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21412057Cohen C, Elion R, Ruane P, Shamblaw D, DeJesus E, Rashbaum B, Chuck SL, Yale K, Liu HC, Warren DR, Ramanathan S, Kearney BP. Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. AIDS. 2011 Mar 27;25(6):F7-12. doi: 10.1097/QAD.0b013e328345766f.
Gilead SciencesLink provided by the sponsor.

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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.

The record lists no contact. Use the official record to reach the sponsor.

30 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 Stribild and Atripla in people with HIV and HIV Infections, run by Gilead Sciences at 30 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 24 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 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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 22 Oct 2012). 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?

The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24 (time frame: Week 24). 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 NCT00869557, 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 4 Jun 2014.