Clinical Trials Register

Summary
EudraCT Number:	2012-003708-11
Sponsor's Protocol Code Number:	GS-US-236-0128
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-01-11
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-003708-11

A.3

Full title of the trial

A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Women.

Studio di Fase 3B randomizzato, in doppio cieco, per valutare l'efficacia e la sicurezza di Elvitegravir/Cobicistat/Emtricitabina/Tenofovir Disoproxil Fumarato verso Atazanavir Potenziato con Ritonavir in associazione con Emtricitabina/Tenofovir Disoproxil Fumarato in pazienti donne affette da HIV-1 naive a trattamenti antiretrovirali.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Clinical research study involving an experimental combination medication called EVG/COBI/FTC/TDF. This is 1 pill containing 2 experimental medications, EVG and COBI, plus 2 medications already approved for the treatment of HIV-1 infection, FTC and TDF. In this study neither the patient or the investigator will know whether the patient is receiving EVG/COBI/FTC/TDF or the comparator drug ritonavir-boosted atazanavir with FTC/TDF.

Studio clinico con una combinazione farmacologica sperimentale chiamata EVG/COBI/FTC/TDF. Una compressa contiene 2 farmaci sperimentali, EVG e COBI, più due farmaci già approvati per il trattamento dell'infezione da HIV-1, FTC e TDF. In questo studio nè i pazienti nè lo sperimentatore sapranno cosa il paziente assumerà: o la combinazione EVG/COBI/FTC/TDF o il farmaco comparatore atazanavir potenziato con ritonavir e FTC/TDF.

A.3.2

Name or abbreviated title of the trial where available

WAVES

A.4.1

Sponsor's protocol code number

GS-US-236-0128

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GILEAD SCIENCE INC.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Gilead Sciences Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Gilead Sciences International Ltd
B.5.2	Functional name of contact point	Clinical Trials Inbox
B.5.3	Address:
B.5.3.1	Street Address	Flowers Building, Granta Park
B.5.3.2	Town/ city	Abington, Cambridge
B.5.3.3	Post code	CB21 6GT
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 1223 897 496
B.5.5	Fax number	+44 1223 897 284
B.5.6	E-mail	clinical.trials@gilead.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	STRIBILD
D.2.1.1.2	Name of the Marketing Authorisation holder	GILEAD SCIENCES INC.
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	EMTRICITABINE
D.3.9.1	CAS number	143491-57-0
D.3.9.4	EV Substance Code	SUB01882MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TENOFOVIR DISOPROXIL FUMARATE
D.3.9.1	CAS number	202138-50-9
D.3.9.4	EV Substance Code	SUB12607MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Cobicistat
D.3.9.2	Current sponsor code	GS-9350
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Elvitegravir
D.3.9.1	CAS number	697761-98-1
D.3.9.2	Current sponsor code	GS-9137
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	REYATAZ*1FL 30CPS 300MG
D.2.1.1.2	Name of the Marketing Authorisation holder	BRISTOL-MYERS SQUIBB Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ATAZANAVIR SULFATE
D.3.9.1	CAS number	229975-97-7
D.3.9.4	EV Substance Code	SUB20595
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	NORVIR*FL 60CPR RIV 100MG
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBOTT Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RITONAVIR
D.3.9.1	CAS number	155213-67-5
D.3.9.4	EV Substance Code	SUB10342MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	TRUVADA*30CPR RIV 200MG/245MG
D.2.1.1.2	Name of the Marketing Authorisation holder	GILEAD SCIENCES Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TENOFOVIR DISOPROXIL FUMARATE
D.3.9.1	CAS number	202138-50-9
D.3.9.4	EV Substance Code	SUB12607MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	EMTRICITABINE
D.3.9.1	CAS number	143491-57-0
D.3.9.4	EV Substance Code	SUB01882MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 4
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Human Immunodeficiency Virus (HIV-1) Infections.

Infezione da virus dell'immunodeficienza umana (HIV-1).

E.1.1.1

Medical condition in easily understood language

Human Immunodeficiency Virus (HIV-1) Infections.

Infezione da virus dell'immunodeficienza umana (HIV-1).

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.1
E.1.2	Level	LLT
E.1.2	Classification code	10020192
E.1.2	Term	HIV-1
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10021881
E.1.2	Term	Infections and infestations
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naïve adult women as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.

• Valutare l'efficacia di un regime contenente Elvitegravir/Cobicistat/Emtricitabina/Tenofovir Disoproxil Fumarato verso Atazanavir Potenziato con Ritonavir in associazione con Emtricitabina/Tenofovir Disoproxil Fumarato in pazienti donne affette da HIV-1 naive a trattamenti antiretrovirali secondo quanto stabilito dal raggiungimento di RNA HIV-1 < 50 copie/ml alla settimana 48.

E.2.2

Secondary objectives of the trial

-To evaluate the safety and tolerability of the two treatment regimens. - To evaluate the change from baseline in CD4+ cell count.

-Valutare la sicurezza e la tollerabilità dei due regimi terapeutici; -Valutare il cambiamento nella conta delle cellule CD4+ rispetto al basale.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

PHARMACOKINETIC/PHARMACODYNAMIC:
Vers:Amend.1
Date:2012/08/28
Title:Contraceptive pharmacokinetic (PK) substudy.
Objectives:An intensive oral contraceptive pharmacokinetic (PK) substudy will be performed in a subset of subjects taking commonly used oral contraceptives on or between the Week 4 and 12 visits. The pharmacokinetics of the hormonal oral contraceptives will be evaluated. Additionally, elvitegravir, emtricitabine, cobicistat, and tenofovir disoproxil fumarate will be evaluated. Pharmacokinetics of the component(s) in the comparator arm may be evaluated.

OTHER SUBSTUDIES:
Dual energy x-ray absorptiometry (DEXA) scans will be performed. DEXA scan will measure lean and body fat composition as well as changes in bone mineral density.

FARMACOCINETICA/FARMACODINAMICA:
Vers:Amend.1
Data:2012/08/28
Titolo:Sottostudio di farmacocinetica dei contraccettivi orali.
Obiettivi:Su un sottogruppo di soggetti che assumono contraccettivi orali di uso comune sarà svolto un sottostudio intensivo sulla farmacocinetica (PK) dei contraccettivi orali. La visita dello studio in cui saranno raccolti i campioni ematici sarà determinata su base individuale e potrebbe coincidere con le visite dello studio della settimana 4, 8 o12 o cadere in un altro momento tra le settimane 4 e 12. Sarà valutata la farmacocinetica dei contraccettivi orali ormonali. Inoltre, saranno valutati elvitegravir, emtricitabina, cobicistat e tenofovir disoproxil fumarato. Può essere altresì valutata la farmacocinetica dei componenti nel braccio comparatore.

ALTRI SOTTOSTUDI:
Al Baseline (Giorno 1), alla settimana 48 e alla visita richiesta in caso di sospensione anticipata del farmaco dello studio (se applicabile), in un sottogruppo di soggetti, saranno eseguite scansioni DEXA (assorbitometria a raggi X a doppia energia) prima della somministrazione del farmaco dello studio. Le scansioni DEXA misureranno la composizione del tessuto corporeo grasso e magro nonché i cambiamenti nella densità minerale ossea.

E.3

Principal inclusion criteria

- Female (at birth), age ≥ 18 years; -Plasma HIV-1 RNA levels ≥ 500 copies/mL at screening; -Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula; -No prior use of any approved or experimental antiretroviral drug for any length of time; -Screening genotype report shows sensitivity to FTC, TDF and ATV/r; -Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant).

-Donne (alla nascita) di età superiore ai 18 anni; -Livelli plasmatici di HIV-1 RNA ≥500 copie/ml allo screening; -Adeguata funzionalità renale: frazione di filtrazione glomerulare stimata ≥70 ml/min secondo la formula di Cockcroft-Gault; -Nessun uso precedente di farmaci antiretrovirali approvati o sperimentali per alcun periodo di tempo; -il report sul genotipo allo screening deve mostrare una sensibilità a FTC,TDF e ATV/r; -ECG nella norma (o se anomalo, valutato dallo sperimentatore come non clinicamente significativo).

E.4

Principal exclusion criteria

- A new AIDS-defining condition diagnosed within the 30 days prior to screening. - Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study. - Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.). - Females who are breastfeeding. - Positive serum pregnancy test (female of childbearing potential). - Have an implanted defibrillator or pacemaker. - Have an ECG PR interval ≥ 220 msec. - Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance. - A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline and must not be anticipated to require systemic therapy during the study. - 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 from the sponsor is prohibited while participating in this trial. - 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.

- Una nuova condizione riconducibile all'AIDS diagnosticata entro 30 giorni prima dello screening. - Soggetti che ricevono o che dovranno ricevere un trattamento farmacologico per l'epatite C nel corso dello studio. - Soggetti che manifestano cirrosi decompensata (per es.: ascite, encefalopatia, ecc.). - Donne che allattano al seno. - Test di gravidanza del siero positivo (donne in età fertile). - Soggetti a cui sia stato impiantato un defibrillatore o un pacemaker. - Soggetti con un intervallo PR nell'ECG ≥ 220 msec. - Uso attuale di alcol o altre sostanze che secondo il Medico Sperimentatore potrebbero interferire con l'osservanza dello studio da parte del soggetto. - Un'anamnesi di malignità negli ultimi 5 anni (prima dello screening) o malignità in corso, a eccezione del sarcoma di Kaposi (KS), carcinoma basale delle cellule o carcinoma squamoso cutaneo non invasivo né resecato. I soggetti con KS sono eleggibili ma non devono aver ricevuto alcuna terapia sistemica per il KS nei 30 giorni precedenti il Baseline e non devono avere in programma una terapia sistemica durante lo studio. - Infezioni gravi attive (diverse dalla HIV-1) che richiedano terapia parenterale antibiotica o antifungina entro 30 giorni dal basale. - È vietato partecipare a qualsiasi altra sperimentazione clinica in concomitanza alla partecipazione a questo studio senza previa approvazione dello sponsor. - Qualsiasi altra condizione clinica o terapia precedente che, secondo il Medico Sperimentatore, renderebbe il soggetto non idoneo allo studio o incapace di osservare lo schema posologico.

E.5 End points

E.5.1

Primary end point(s)

The proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis.

La percentuale di soggetti con HIV-1 RNA <50 copie/ml alla settimana 48, come definito dalle analisi snapshot della Food and Drug Administration (FDA).

E.5.1.1

Timepoint(s) of evaluation of this end point

48 weeks.

48 settimane.

E.5.2

Secondary end point(s)

-The proportion of subjects who have virologic failure, as defined by the FDA snapshot analysis; -The change from baseline in CD4+ cell count.

-La percentuale di soggetti che presentano un fallimento virologico, come definito dalle analisi snapshot della FDA; -La variazione nella conta delle cellule CD4+ dal basale.

E.5.2.1

Timepoint(s) of evaluation of this end point

48 weeks

48 settimane

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Other health-related outcomes.

Altri isultati legati alla salute.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Mexico

Puerto Rico

Russian Federation

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

484

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

128

F.4.2.2

In the whole clinical trial

510

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Subjects who were randomized to receive EVG/COBI/FTC/TDF in countries where the EVG/COBI/FTC/TDF STR is not commercially available at the end of Week 48 will be given the option to receive the open-label EVG/COBI/FTC/TDF STR until it becomes commercially available, or until Gilead Sciences elects to terminate clinical development of the EVG/COBI/FTC/TDF STR in that country.

I soggetti che alla randomizzazione riceveranno EVG/COBI/FTC/TDF in paesi dove EVG/COBI/FTC/TDF STR non è disponibile in commercio, alla fine delle 48 settimane gli sarà data la possibilità di ricevere il farmaco nel braccio in aperto EVG/COBI/FTC/TDF STR fino a quando non sarà disponibile in commercio, o fino a quando Gilead Sciences non terminerà lo sviluppo clinico di EVG/COBI/FTC/TDF STR in quel paese.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-01-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-04-09

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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