Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

• Sponsor: Gilead Sciences (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02044822
• Collaborator: (none)
• Enrollment: 102
• Locations: 56
• Arm: 1
• Actual Duration (Months): 21.4
• Patients Per Site: 1.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

Condition or Disease	Intervention/Treatment	Phase
B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion	Drug: Idelalisib; Drug: Rituximab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
• Actual Study Start Date: Aug 6, 2014
• Actual Primary Completion Date: Apr 27, 2016
• Actual Study Completion Date: May 17, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Idelalisib + rituximab Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).	Drug: Idelalisib; 150 mg tablets administered orally twice daily; Other Names: GS-1101 CAL-101 Zydelig® ; Drug: Rituximab; 375 mg/m^2 administered intravenously once weekly x 8 weeks; Other Names: Rituxan

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate []

   Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).

Secondary Outcome Measures

1. Duration of Response []

   Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.

2. Nodal Response Rate []

   Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.

3. Complete Response Rate []

   Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.

4. Progression-Free Survival []

   Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.

5. Overall Survival []

   Overall survival was defined as the interval from the start of study treatment to death from any cause.

6. Minimal Residual Disease Negativity Rate at Week 36 []

   Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Documented diagnosis of B-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia 2008

• Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ hybridization (FISH) testing

• No prior therapy for CLL other than corticosteroids for disease complications

• CLL that warrants treatment

• Presence of measurable lymphadenopathy

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Key Exclusion Criteria:

• Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)

• Known presence of myelodysplastic syndrome

• History of a non-CLL malignancy except for the following:

• the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment, or

• carcinoma in situ of the cervix, or

• adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or

• asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or

• ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or

• other adequately treated Stage 1 or 2 cancer currently in complete remission

• Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment

• Ongoing liver injury

• History of noninfectious pneumonitis

• Ongoing inflammatory bowel disease

• History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

• Ongoing immunosuppressive therapy other than corticosteroids

• Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment

• Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona	United States	85710
2	Innovative Clinical Research Institute	Whittier	California	United States	90603
3	Rocky Mountain Cancer Centers	Boulder	Colorado	United States	80303
4	The University of Chicago Medicine	Chicago	Illinois	United States	60637
5	Illinois Cancer Specialists	Niles	Illinois	United States	60714
6	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
7	Duke University	Durham	North Carolina	United States	27705
8	GHS Cancer Institute	Greenville	North Carolina	United States	29615
9	Compass Oncology	Portland	Oregon	United States	97213
10	Willamette Valley Cancer Center and Research Institute	Springfield	Oregon	United States	97477
11	Hospital of the University of Pennsylvania, Abramson Cancer Center	Philadelphia	Pennsylvania	United States	19104
12	St Vincent's Hospital, Sydney	Darlinghurst	New South Wales	Australia	2010
13	St George Hospital	Kogarah	New South Wales	Australia	2217
14	Icon Cancer Foundation	South Brisbane	Queensland	Australia	4101
15	St Vincent's Hospital, Melbourne	Fitzroy	Victoria	Australia	3065
16	Liverpool Hospital	Liverpool		Australia	NSW 2170
17	Innsbruck University Hospital, Inner Medicine,	Innsbruck		Austria	A-6020
18	Univ. Klinik für Innere Medizin III LKH	Salzburg		Austria	5020
19	Medizinische Universität Wien, Univ. Klinik f. Innere Med. I, Abteilung für Hämatologie und Hämostaseologie	Vienna		Austria	1090
20	AZ Sint-Jan AV Brugge-Oostende	Brugge		Belgium	8000
21	University Hospital Leuven	Leuven		Belgium	3000
22	University Hospital	Brno		Czechia
23	Faculty Hospital Hradec Kralove	Hradec Kralove		Czechia	500 05
24	Hemato-Onkologicka Klinika Fn	Olomuc		Czechia
25	Faculty hospital Ostrava	Ostrava-Poruba		Czechia	70852
26	Faculty Hospital Kralovske Vinohrady	Prague 10		Czechia	10034
27	Vseobecna Fakultim Nemocnice	Praha		Czechia	12808
28	Aalborg University Hospital	Aalborg		Denmark	9100
29	Centre Hospitalier Universitaire Hôpital Avicenne	Bobigny		France	93009
30	CHRU de Lille, Hopital Claude Huriez	Lille		France	59037
31	Centre Hospitalier Universitaire Nancy	Nancy		France	54511
32	Hopital Pitie-Salpetriere	Paris cedex 13		France	75651
33	University of Debrecen HSC Institute of internal Medicine, Department of Hematology	Debrecen		Hungary	4032
34	Institute of Hematology "L. e A. Seràgnoli"	Bologna		Italy	40138
35	A.O.Spedali Civili Brescia	Brescia		Italy	25123
36	A.O.Niguarda Ca' Granda	Milan		Italy	20162
37	Azienda Ospedaliero Universitaria Policlinico di Modena	Modena		Italy	41124
38	SCDU Medicina II ed Ematologia, A.O.U. San Luigi Gonzaga	Orbassano		Italy	10043
39	Uniwersyteckie Centrum Kliniczne	Gdańsk	Pomorskie	Poland	80-952
40	Szpital Specjalistyczny w Brzozowie	Brzozow		Poland	36-200
41	Malopolskie Centrum Medyczne s.c.	Krakow		Poland	30-510
42	Wojewodzki Szpital Specjalistyczny	Lodz		Poland	93-510
43	Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego	Warszawa		Poland	02-781
44	Samodzielny Publiczny Szpital Kliniczny	Wroclaw		Poland	50-367
45	Centro Hospitalar De Lisboa Norte, E.P.E. - Hospital Santa Maria	Lisbon		Portugal	1649-035
46	IPO Porto Francisco Gentil, E.P.E	Porto		Portugal	4200-072
47	Emergency County Clinical Hospital Brasov	Brasov		Romania	500326
48	Spitalul Clinic Colentina	Bucharest		Romania	20125
49	Institutul Regional de Oncologie Iasi	Iasi		Romania	700348
50	Hospital Universitario Marques de Valdecilla	Santander	Cantabria	Spain	39008
51	Hospital Clinic	Barcelona	Cataluña	Spain	08036
52	Hospital Universitario Puerta De Hierro	Madrid		Spain	28222
53	Hospital Clinico Universitario De Valencia (Chuv)	Valencia		Spain	46010
54	Saint James's University Hospital	Leeds		United Kingdom	LS9 7TF
55	Royal Liverpool & Broadgreen Univ. Hospitals	Liverpool		United Kingdom	L7 8XP
56	University Hospital Southampton NHS Trust	Southampton		United Kingdom	16

Sponsors and Collaborators

• Gilead Sciences

Investigators

• Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT02044822
• Other Study ID Numbers: GS-US-312-0133; 2013-003314-41
• First Posted: Jan 24, 2014
• Last Update Posted: Nov 19, 2018
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gilead Sciences: Chronic Lymphocytic Leukemia; CLL
• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Rituximab; Idelalisib

Study Results

Participant Flow

Recruitment Details	Participants were enrolled at study sites in Australia, Europe, and the United States. The first participant was screened on 06 August 2014. The last study visit occurred on 17 May 2016.
Pre-assignment Detail	130 participants were screened.

Arm/Group Title	Idelalisib + Rituximab
Arm/Group Description	Idelalisib (Zydelig®) 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Period Title: Overall Study
STARTED	102
COMPLETED	9
NOT COMPLETED	93

Baseline Characteristics

Arm/Group Title	Idelalisib + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Overall Participants	102
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (9.9)
Sex: Female, Male (Count of Participants)
Female	44 43.1%
Male	58 56.9%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 2%
Black or African American	2 2%
White	94 92.2%
Not Permitted	4 3.9%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	6 5.9%
Not Hispanic or Latino	91 89.2%
Not Permitted	5 4.9%
Region of Enrollment (participants) [Number]
Romania	4 3.9%
Hungary	2 2%
United States	19 18.6%
United Kingdom	11 10.8%
Portugal	2 2%
Spain	7 6.9%
Austria	3 2.9%
Czech Republic	9 8.8%
Belgium	2 2%
Denmark	1 1%
Poland	15 14.7%
Italy	14 13.7%
Australia	6 5.9%
France	7 6.9%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate
Description	Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).

Outcome Measure Data

Analysis Population Description

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Arm/Group Title	Idelalisib + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Measure Participants	0

2. Secondary Outcome

Title	Duration of Response
Description	Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.

Outcome Measure Data

Analysis Population Description

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Arm/Group Title	Idelalisib + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Measure Participants	0

3. Secondary Outcome

Title	Nodal Response Rate
Description	Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.

Outcome Measure Data

Analysis Population Description

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Arm/Group Title	Idelalisib + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Measure Participants	0

4. Secondary Outcome

Title	Complete Response Rate
Description	Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.

Outcome Measure Data

Analysis Population Description

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Arm/Group Title	Idelalisib + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Measure Participants	0

5. Secondary Outcome

Title	Progression-Free Survival
Description	Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.

Outcome Measure Data

Analysis Population Description

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Arm/Group Title	Idelalisib + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Measure Participants	0

6. Secondary Outcome

Title	Overall Survival
Description	Overall survival was defined as the interval from the start of study treatment to death from any cause.

Outcome Measure Data

Analysis Population Description

Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.

Arm/Group Title	Idelalisib + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Measure Participants	0

7. Secondary Outcome

Title	Minimal Residual Disease Negativity Rate at Week 36
Description	Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.

Outcome Measure Data

Analysis Population Description

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

Arm/Group Title	Idelalisib + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
Measure Participants	0

Adverse Events

Time Frame	Up to 17 months plus 30 days
Adverse Event Reporting Description	Intent-to-Treat Analysis Set
Arm/Group Title	Idelalisib + Rituximab
Arm/Group Description	Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
All Cause Mortality
	Idelalisib + Rituximab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Idelalisib + Rituximab
	Affected / at Risk (%)	# Events
Total	46/102 (45.1%)
Blood and lymphatic system disorders
Agranulocytosis	1/102 (1%)
Febrile neutropenia	3/102 (2.9%)
Thrombocytopenia	1/102 (1%)
Cardiac disorders
Atrial fibrillation	2/102 (2%)
Cardiac failure	1/102 (1%)
Coronary artery disease	1/102 (1%)
Gastrointestinal disorders
Colitis	6/102 (5.9%)
Diarrhoea	6/102 (5.9%)
Diarrhoea haemorrhagic	1/102 (1%)
Enterocolitis	1/102 (1%)
Gastrointestinal haemorrhage	1/102 (1%)
Glossitis	1/102 (1%)
Mouth ulceration	1/102 (1%)
Oral mucosal eruption	1/102 (1%)
Stomatitis	1/102 (1%)
General disorders
Malaise	1/102 (1%)
Pyrexia	11/102 (10.8%)
Infections and infestations
Appendicitis	1/102 (1%)
Clostridium difficile colitis	1/102 (1%)
Conjunctivitis	1/102 (1%)
Cytomegalovirus infection	1/102 (1%)
Gastroenteritis	1/102 (1%)
Herpes zoster	1/102 (1%)
Influenza	1/102 (1%)
Intestinal sepsis	1/102 (1%)
Lower respiratory tract infection	2/102 (2%)
Lower respiratory tract infection fungal	1/102 (1%)
Oral candidiasis	1/102 (1%)
Pneumocystis jirovecii infection	1/102 (1%)
Pneumocystis jirovecii pneumonia	1/102 (1%)
Pneumonia	5/102 (4.9%)
Pneumonia bacterial	1/102 (1%)
Pneumonia influenzal	1/102 (1%)
Pneumonia pneumococcal	1/102 (1%)
Pneumonia pseudomonal	1/102 (1%)
Pseudomonal bacteraemia	1/102 (1%)
Respiratory tract infection	1/102 (1%)
Sepsis	1/102 (1%)
Septic shock	2/102 (2%)
Urinary tract infection	1/102 (1%)
Injury, poisoning and procedural complications
Infusion related reaction	1/102 (1%)
Investigations
Alanine aminotransferase increased	2/102 (2%)
Aspartate aminotransferase increased	2/102 (2%)
Body temperature increased	1/102 (1%)
Liver function test increased	1/102 (1%)
Transaminases increased	2/102 (2%)
Metabolism and nutrition disorders
Dehydration	1/102 (1%)
Diabetic ketoacidosis	1/102 (1%)
Dyslipidaemia	1/102 (1%)
Hyperglycaemia	1/102 (1%)
Metabolic acidosis	1/102 (1%)
Tumour lysis syndrome	4/102 (3.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/102 (1%)
Muscular weakness	1/102 (1%)
Polymyalgia rheumatica	1/102 (1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/102 (1%)
Chronic lymphocytic leukaemia	1/102 (1%)
Nervous system disorders
Dysgeusia	1/102 (1%)
Facial nerve disorder	1/102 (1%)
Psychiatric disorders
Confusional state	1/102 (1%)
Renal and urinary disorders
Acute kidney injury	2/102 (2%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/102 (1%)
Cough	1/102 (1%)
Epistaxis	1/102 (1%)
Hiccups	1/102 (1%)
Interstitial lung disease	1/102 (1%)
Laryngeal pain	1/102 (1%)
Pleuritic pain	1/102 (1%)
Pneumonitis	2/102 (2%)
Pulmonary embolism	1/102 (1%)
Skin and subcutaneous tissue disorders
Dermatitis exfoliative	1/102 (1%)
Eczema	1/102 (1%)
Psoriasis	1/102 (1%)
Rash	2/102 (2%)
Rash maculo-papular	2/102 (2%)
Vascular disorders
Hypotension	1/102 (1%)
Other (Not Including Serious) Adverse Events
	Idelalisib + Rituximab
	Affected / at Risk (%)	# Events
Total	98/102 (96.1%)
Blood and lymphatic system disorders
Anaemia	14/102 (13.7%)
Neutropenia	24/102 (23.5%)
Thrombocytopenia	10/102 (9.8%)
Gastrointestinal disorders
Abdominal pain	8/102 (7.8%)
Constipation	15/102 (14.7%)
Diarrhoea	36/102 (35.3%)
Dyspepsia	8/102 (7.8%)
Mouth ulceration	6/102 (5.9%)
Nausea	19/102 (18.6%)
Vomiting	17/102 (16.7%)
General disorders
Asthenia	15/102 (14.7%)
Chills	13/102 (12.7%)
Fatigue	16/102 (15.7%)
Oedema peripheral	11/102 (10.8%)
Pyrexia	24/102 (23.5%)
Infections and infestations
Bronchitis	6/102 (5.9%)
Nasopharyngitis	10/102 (9.8%)
Oral candidiasis	6/102 (5.9%)
Respiratory tract infection	6/102 (5.9%)
Upper respiratory tract infection	7/102 (6.9%)
Injury, poisoning and procedural complications
Infusion related reaction	6/102 (5.9%)
Investigations
Alanine aminotransferase increased	39/102 (38.2%)
Aspartate aminotransferase increased	22/102 (21.6%)
Transaminases increased	6/102 (5.9%)
Weight decreased	8/102 (7.8%)
Metabolism and nutrition disorders
Decreased appetite	9/102 (8.8%)
Hypokalaemia	10/102 (9.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	8/102 (7.8%)
Back pain	10/102 (9.8%)
Myalgia	8/102 (7.8%)
Pain in extremity	8/102 (7.8%)
Nervous system disorders
Dizziness	8/102 (7.8%)
Headache	10/102 (9.8%)
Psychiatric disorders
Insomnia	7/102 (6.9%)
Respiratory, thoracic and mediastinal disorders
Cough	19/102 (18.6%)
Dyspnoea	8/102 (7.8%)
Epistaxis	6/102 (5.9%)
Skin and subcutaneous tissue disorders
Pruritus	8/102 (7.8%)
Rash	28/102 (27.5%)
Rash maculo-papular	7/102 (6.9%)
Vascular disorders
Hypertension	7/102 (6.9%)

Limitations/Caveats

Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years