Acquired Immunodeficiency SyndromePhase 2/3NCT01721109
Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
A Phase 2/3 study testing EVG/COBI/FTC/TDF in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 18 sites in 3 countries.
Trial summary
The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen (STR) (Part A) and to evaluate the safety and tolerability of EVG/COBI/FTC/TDF STR through… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, HIV Infections
- What is being tested?
- EVG/COBI/FTC/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 sitesin 3 countries
- Study dates
- 6 Dec 2012to 29 Jan 2018
- Phase
- Phase 2/3
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12 years to < 18 years of age at baseline
- Able to give written assent prior to any screening evaluations
- Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements
- Plasma HIV-1 RNA levels of ≥ 1,000 copies/mL
- CD4+ cell count > 100 cells/µL
- Weight ≥ 35 kg (77 lbs)
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- Screening genotype report must show sensitivity to FTC and TDF
- Able to swallow oral tablets
- Adequate renal function
- Clinically normal ECG
- Documented screening for active pulmonary tuberculosis per local standard of care within 6 months of a screening visit
- Hepatic transaminases ≤ 5 x upper limit of normal
- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
- Individuals with a positive Hepatitis B surface antigen screening test can participate in the study, providing that alternate therapy (other than TDF) for chronic Hepatitis B infection is available as a part of local standard of care
- Adequate hematologic function
- Negative serum pregnancy test for all females
- Males and females of childbearing potential must agree to utilize highly effective contraception methods while on study treatment or agree to abstain from heterosexual intercourse throughout the study period and for 30 days following the last dose of study drug
- Males must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product
- Must be willing and able to comply with all study requirements
- Life expectancy ≥ 1 year
Who cannot join
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Prior treatment with any approved or investigational or experimental anti HIV-1 drug for any length of time (other than that given for prevention of mother-to-child transmission)
- Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit
- Anticipated to require rifamycin treatment for mycobacterial infection while participating in the study. Note: prophylactic Isoniazid (INH) therapy for latent tuberculosis (TB) treatment is allowed.
- Individuals experiencing decompensated cirrhosis
- Pregnant or lactating females
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- Have any serious or active medical or psychiatric illness which would interfere with treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, hematological, hepatic, pulmonary, endocrine, central nervous, gastrointestinal, vascular, metabolic, immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to the study dosing.
- Current alcohol or substance abuse that will potentially interfere with compliance
- Have history of significant drug sensitivity or drug allergy
- Known hypersensitivity to the study drugs, the metabolites or formulation excipients
- Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening or expected to receive these agents during the study
- A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
- Have previously participated in an investigational trial involving administration of any investigational agent within 30 days prior to the study dosing
- Participation in any other clinical trial without prior approval from sponsor is prohibited while participating in this trial
- Receiving ongoing therapy with any disallowed medications, including drugs not to be used with EVG, COBI, FTC, TDF or individuals with any known allergies to the excipients of EVG/COBI/FTC/TDF STR tablets
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States7 sites
University of Chicago
Chicago, Illinois, 60637
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
New York University School of Medicine
New York, New York, 10016
East Bay AIDS Center Medical Group
Oakland, California, 94609
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
University of South Florida - Department of Pediatrics
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
South Africa7 sites
Desmond Tutu HIV Research Centre
Cape Town, 7925
Mpati Medical Center
Dundee, 3000
Dr Latiff Private Practice
Durban, KwaZulu-Natal, 4001
Rahima Moosa Mother and Child Hospital (Wits)
Johannesburg, Gauteng, 2112
Clinical HIV Research Unit
Johannesburg, 2092
Perinatal HIV Research Unit
Soweto, 2013
University of Stellenbosch
Stellenbosch, 7602
Thailand4 sites
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, 10330
Siriraj Hospital, Mahidol University
Bangkok, 10700
Queen Savang Vadhana Memorial Hospital
Chon Buri, 20110
Srinakarind Hospital
Khon Kaen, 40002
About this study
Official title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents
The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen (STR) (Part A) and to evaluate the safety and tolerability of EVG/COBI/FTC/TDF STR through Week 48 (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.
A total of 50 adolescent participants (12 to < 18 years of age) will be enrolled to receive EVG/COBI/FTC/TDF as follows:
- Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK, and confirm the dose, with the intent to enroll at least 4 participants 12 to < 15 and at least 4 participants 15 to < 18 years of age.
- Part B: Following confirmation of EVG exposure in at least 12 participants from Part A, 34 to 38 participants in addition to those enrolled in Part A will be enrolled to evaluate the safety, tolerability, and antiviral activity of EVG/COBI/FTC/TDF STR.
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections
- Being tested
- EVG/COBI/FTC/TDF
- Keywords
- Adolescents, HIV-1, HIV, Treatment Naive
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVG/COBI/FTC/TDFDrug
Also called Stribild®
150/150/200/300 mg STR administered orally once daily with food
| Study group | Role | What they receive |
|---|---|---|
| EVG/COBI/FTC/TDF | Experimental | Participants will receive treatment for 48 weeks and then had the option to enter an Extension Phase to receive EVG/COBI/FTC/TDF until 1) the age of 18, 2) EVG/COBI/FTC/TDF becomes commercially available in the country the participant is enrolled, or 3) Gilead elects to terminate the development of EVG/COBI/FTC/TDF in that country. Receives: Drug: EVG/COBI/FTC/TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measured: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) and All Treatment-Emergent Adverse Events (AEs)
Measured: Up to Week 48 plus 30 days
Secondary outcomes (8)
For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Measured: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI
Cmax is defined as the maximum concentration of drug.
Measured: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measured: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis
Measured: Weeks 24 and 48
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis
Measured: Weeks 24 and 48
Change From Baseline in Plasma log10 HIV-1 RNA at Weeks 24 and 48
Measured: Baseline; Weeks 24 and 48
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Measured: Baseline; Weeks 24 and 48
Change From Baseline in CD4 Percentage at Weeks 24 and 48
Measured: Baseline; 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.
- First posted5 Nov 2012 (estimated)
- Study start6 Dec 2012
- Primary completion22 Oct 2015
- Study completion29 Jan 2018
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 (4)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721109
- Sponsor's protocol ID
- GS-US-236-0112
- Other IDs
- 2015-000313-40, 2015
- Status last verified
- Jul 2018
- First submitted
- 1 Nov 2012
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Gaur A, Fourie J, Chokephaibulkit K, Bekker L-G, Yin X, Custodio J, Bennett S, Cheng A, Quirk E. Pharmacokinetics, Efficacy and Safety of an Integrase Inhibitor-Based Single-Tablet Regimen in HIV-Infected Treatment-Naïve Adolescents. 21st Conference on Retroviruses and Opportunistic Infections (CROI). March 2014. Boston, MA, USA
Chokephaibulkit K, Gaur A, Fourie J, Bekker L-G, Shao Y, Custodio J, Bennett S, Cheng A, Quirk E. Safety and Efficacy of the Integrase Inhibitor-Based Stribild Single-Tablet Regimen in HIV-Infected Adolescents Through 24 Weeks of Treatment. 20th International AIDS Conference. July 2014. Melbourne, Australia
Porter DP, Bennett S, Quirk E, Miller MD, White KL. Lack of Emergent Resistance in HIV-1-Infected Adolescents on Elvitegravir-Based STRs. 22nd Conference on Retroviruses and Opportunistic Infections (CROI). February 2015. Seattle, WA, USA
Kizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Chokephaibulkit K, Fourie J, Bekker LG, Shao Y, Bennett S, Quirk E. Changes in renal laboratory markers and bone mineral density in treatment-naïve HIV-1-infected adolescents initiating INSTI-based single-tablet regimens containing tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF). 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention. July 2015. Vancouver, Canada
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents
- ClinicalTrials.gov ID
- NCT01721109
- Acronym / sponsor ID
- GS-US-236-0112
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections
- Keywords
- Adolescents, HIV-1, HIV, Treatment Naive
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2012 (actual)
- Primary completion
- 22 Oct 2015 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 5 Nov 2012 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single-tablet regimen (STR) (Part A) and to evaluate the safety and tolerability of EVG/COBI/FTC/TDF STR through Week 48 (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents.
A total of 50 adolescent participants (12 to < 18 years of age) will be enrolled to receive EVG/COBI/FTC/TDF as follows:
- Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK, and confirm the dose, with the intent to enroll at least 4 participants 12 to < 15 and at least 4 participants 15 to < 18 years of age.
- Part B: Following confirmation of EVG exposure in at least 12 participants from Part A, 34 to 38 participants in addition to those enrolled in Part A will be enrolled to evaluate the safety, tolerability, and antiviral activity of EVG/COBI/FTC/TDF STR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVG/COBI/FTC/TDF | Experimental | Drug: EVG/COBI/FTC/TDFParticipants will receive treatment for 48 weeks and then had the option to enter an Extension Phase to receive EVG/COBI/FTC/TDF until 1) the age of 18, 2) EVG/COBI/FTC/TDF becomes commercially available in the country the participant is enrolled, or 3) Gilead elects to terminate the development of EVG/COBI/FTC/TDF in that country. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- 12 years to < 18 years of age at baseline
- Able to give written assent prior to any screening evaluations
- Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements
- Plasma HIV-1 RNA levels of ≥ 1,000 copies/mL
- CD4+ cell count > 100 cells/µL
Key exclusion criteria (16 listed)
- A new AIDS-defining condition diagnosed within the 30 days prior to screening
- Prior treatment with any approved or investigational or experimental anti HIV-1 drug for any length of time (other than that given for prevention of mother-to-child transmission)
- Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit
- Anticipated to require rifamycin treatment for mycobacterial infection while participating in the study. Note: prophylactic Isoniazid (INH) therapy for latent tuberculosis (TB) treatment is allowed.
- Individuals experiencing decompensated 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 |
|---|---|---|
| EVG/COBI/FTC/TDFAlso: Stribild®150/150/200/300 mg STR administered orally once daily with food | Drug | EVG/COBI/FTC/TDF |
Primary outcome
For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG
Time frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Incidence of Treatment-Emergent Serious Adverse Events (SAEs) and All Treatment-Emergent Adverse Events (AEs)
Time frame: Up to Week 48 plus 30 days
8 secondary outcomes
For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI
Time frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI
Time frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI
Time frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis
Time frame: Weeks 24 and 48
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis
Time frame: Weeks 24 and 48
Change From Baseline in Plasma log10 HIV-1 RNA at Weeks 24 and 48
Time frame: Baseline; Weeks 24 and 48
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Time frame: Baseline; Weeks 24 and 48
Change From Baseline in CD4 Percentage at Weeks 24 and 48
Time frame: Baseline; Weeks 24 and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationGaur A, Fourie J, Chokephaibulkit K, Bekker L-G, Yin X, Custodio J, Bennett S, Cheng A, Quirk E. Pharmacokinetics, Efficacy and Safety of an Integrase Inhibitor-Based Single-Tablet Regimen in HIV-Infected Treatment-Naïve Adolescents. 21st Conference on Retroviruses and Opportunistic Infections (CROI). March 2014. Boston, MA, USA
- Results publicationChokephaibulkit K, Gaur A, Fourie J, Bekker L-G, Shao Y, Custodio J, Bennett S, Cheng A, Quirk E. Safety and Efficacy of the Integrase Inhibitor-Based Stribild Single-Tablet Regimen in HIV-Infected Adolescents Through 24 Weeks of Treatment. 20th International AIDS Conference. July 2014. Melbourne, Australia
- Results publicationPorter DP, Bennett S, Quirk E, Miller MD, White KL. Lack of Emergent Resistance in HIV-1-Infected Adolescents on Elvitegravir-Based STRs. 22nd Conference on Retroviruses and Opportunistic Infections (CROI). February 2015. Seattle, WA, USA
- Results publicationKizito H, Gaur A, Prasitsuebsai W, Rakhmanina N, Chokephaibulkit K, Fourie J, Bekker LG, Shao Y, Bennett S, Quirk E. Changes in renal laboratory markers and bone mineral density in treatment-naïve HIV-1-infected adolescents initiating INSTI-based single-tablet regimens containing tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF). 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention. July 2015. Vancouver, Canada
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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.
Gilead Study Director study director
Gilead Sciences
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EVG/COBI/FTC/TDF in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by Gilead Sciences at 18 sites in 3 countries.
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 20 inclusion and 16 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 17 Aug 2018. 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, South Africa, Thailand. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 10 Apr 2017). 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?
For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG (time frame: Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10). The study lists 2 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 NCT01721109, which also lists 4 linked publications.
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 17 Aug 2018.