Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT01095796

First received: March 17, 2010

Last updated: December 10, 2012

Last verified: December 2012

History of Changes

Results First Received: September 20, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	HIV HIV Infections
Interventions:	Drug: Stribild Drug: Atripla

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 97 sites in the United States and 5 sites in Puerto Rico. The first participant was screened on 16 March 2010. The last participant observation for the Week 48 analysis was on 10 August 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
917 participants were screened; 707 were randomized (353 to the Stribild group and 354 to the Atripla group) of which 66.5% (470) had screening HIV-1 ribonucleic acid (RNA) ≤ 100,000 copies/mL. A total of 700 randomized participants received at least 1 dose of study medication and comprised the safety and intent-to treat (ITT) analysis sets.

Reporting Groups

	Description
Stribild	Double-blind Stribild (elvitegravir [EVG] 150 mg/GS-9350 [cobicistat; COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) once daily (QD) and placebo to match Atripla once daily prior to bedtime (QHS)
Atripla	Double-blind Atripla (efavirenz [EFV] 150 mg/FTC 200 mg/TDF 300 mg) QHS and placebo to match Stribild QD

Participant Flow: Overall Study

	Stribild	Atripla
STARTED	348	352
COMPLETED	0	0
NOT COMPLETED	348	352
Adverse Event	12	18
Death	1	1
Pregnancy	1	0
Lack of Efficacy	5	4
Physician Decision	1	0
Withdrawal by Subject	3	5
Lost to Follow-up	10	12
Participant Noncompliance	3	6
Protocol Violation	1	0
Subjects Still on Study Treatment	311	306

Baseline Characteristics

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Reporting Groups

	Description
Stribild	Double-blind Stribild QD and placebo to match Atripla QHS
Atripla	Double-blind Atripla QHS and placebo matching Stribild QD
Total	Total of all reporting groups

Baseline Measures

	Stribild	Atripla	Total
Number of Participants [units: participants]	348	352	700
Age [units: years] Mean ± Standard Deviation	38 ± 10.4	38 ± 10.6	38 ± 10.5
Gender [units: participants]
Female	41	36	77
Male	307	316	623
Race/Ethnicity, Customized [units: participants]
American Indian or Alaska Native	2	4	6
Asian	6	10	16
Black or African Heritage	106	91	197
Native Hawaiian or Pacific Islander	4	1	5
White	214	227	441
Other	16	19	35
Region of Enrollment [units: participants]
United States	348	352	700
HIV Disease Status [units: participants]
Asymptomatic	290	295	585
Symptomatic HIV Infections	30	33	63
AIDS	28	24	52
Hepatitis B Virus (HBV) Infection Status [units: participants]
Negative	343	343	686
Positive	5	9	14
Hepatitis C Virus (HCV) Infection Status [units: participants]
Negative	331	337	668
Positive	17	15	32
HIV-1 RNA Category (copies/mL) [units: participants]
≤ 100,000	230	236	466
> 100,000	118	116	234
CD4 Cell Count (/µL) [units: participants]
≤ 50	7	6	13
51 to ≤ 200	36	45	81
201 to ≤ 350	112	96	208
351 to ≤ 500	113	136	249
> 500	80	69	149

Outcome Measures

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1. Primary:

The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL [ Time Frame: Week 48 ]

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2. Secondary:

The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm [ Time Frame: Week 48 ]

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3. Secondary:

The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 [ Time Frame: Baseline to Week 48 ]

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4. Secondary:

The Percentage of Participants With HIV-1 RNA < 50 Copies/mL [ Time Frame: Week 48 ]

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Serious Adverse Events

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Time Frame	Adverse events are reported for the double-blind treatment of Stribild or Atripla up to the Week 48 database cut
Additional Description	No text entered.

Reporting Groups

	Description
Stribild	Double-blind Stribild QD and placebo to match Atripla QHS
Atripla	Double-blind Atripla QHS and placebo to match Stribild QD

Serious Adverse Events

	Stribild	Atripla
Total, serious adverse events
# participants affected / at risk	41/348 (11.78%)	24/352 (6.82%)
Blood and lymphatic system disorders
Thrombocytopenia ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Cardiac disorders
Acute myocardial infarction ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Intracardiac mass ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Gastrointestinal disorders
Abdominal pain ^{† 1}
# participants affected / at risk	1/348 (0.29%)	1/352 (0.28%)
Colitis ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Gastritis ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Pancreatitis ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Proctalgia ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Vomiting ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
General disorders
Fatigue ^{† 1}
# participants affected / at risk	2/348 (0.57%)	0/352 (0.00%)
Pyrexia ^{† 1}
# participants affected / at risk	0/348 (0.00%)	2/352 (0.57%)
Asthenia ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Non-cardiac chest pain ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Hepatobiliary disorders
Cholecystitis ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Cholelithiasis ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Hepatitis alcoholic ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Liver injury ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Immune system disorders
Anaphylactic reaction ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Antiphospholipid syndrome ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Immune reconstitution syndrome ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Infections and infestations
Pneumonia ^{† 1}
# participants affected / at risk	4/348 (1.15%)	1/352 (0.28%)
Appendicitis ^{† 1}
# participants affected / at risk	3/348 (0.86%)	1/352 (0.28%)
Cellulitis ^{† 1}
# participants affected / at risk	4/348 (1.15%)	0/352 (0.00%)
Gastroenteritis ^{† 1}
# participants affected / at risk	2/348 (0.57%)	0/352 (0.00%)
Anogenital warts ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Bronchitis ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Bronchitis bacterial ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Diarrhoea infectious ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Diverticulitis ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Meningitis viral ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Muscle abscess ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Neurosyphilis ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Pulmonary tuberculosis ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Urinary tract infection ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Viral infection ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Injury, poisoning and procedural complications
Alcohol poisoning ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Lumbar vertebral fracture ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Investigations
Alanine aminotransferase increased ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Aspartate aminotransferase increased ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Transaminase increased ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Metabolism and nutrition disorders
Dehydration ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Diabetic ketoacidosis ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Musculoskeletal and connective tissue disorders
Synovitis ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma ^{† 1}
# participants affected / at risk	2/348 (0.57%)	0/352 (0.00%)
Adenocarcinoma ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Anal cancer ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Bladder cancer recurrent ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Disseminated large cell lymphoma ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Kaposi's sarcoma ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Lymphoma ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Malignant melanoma ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Metastatic neoplasm ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Nervous system disorders
Headache ^{† 1}
# participants affected / at risk	2/348 (0.57%)	1/352 (0.28%)
Syncope ^{† 1}
# participants affected / at risk	1/348 (0.29%)	1/352 (0.28%)
Convulsion ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Grand mal convulsion ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Presyncope ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Psychiatric disorders
Completed suicide ^{† 1}
# participants affected / at risk	1/348 (0.29%)	1/352 (0.28%)
Depression ^{† 1}
# participants affected / at risk	1/348 (0.29%)	1/352 (0.28%)
Suicide attempt ^{† 1}
# participants affected / at risk	0/348 (0.00%)	2/352 (0.57%)
Alcoholism ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Bipolar disorder ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Renal and urinary disorders
Renal failure ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Reproductive system and breast disorders
Pelvic pain ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Respiratory, thoracic and mediastinal disorders
Asthma ^{† 1}
# participants affected / at risk	1/348 (0.29%)	1/352 (0.28%)
Dyspnoea ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Dyspnoea exertional ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Respiratory failure ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Skin and subcutaneous tissue disorders
Rash maculo-papular ^{† 1}
# participants affected / at risk	0/348 (0.00%)	1/352 (0.28%)
Vascular disorders
Deep vein thrombosis ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Hypertension ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)
Hypertensive crisis ^{† 1}
# participants affected / at risk	1/348 (0.29%)	0/352 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA (14.0)

Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Christophe Beraud, Director, Regulatory Affairs
Organization: Gilead Sciences, Inc.
phone: (650) 522-5093
e-mail: christophe.beraud@gilead.com

Publications of Results:

Sax PE, DeJesus E, Mills A, Zolopa A, Cohen C, Wohl D, Gallant JE, Liu HC, Zhong L, Yale K, White K, Kearney BP, Szwarcberg J, Quirk E, Cheng AK; GS-US-236-0102 study team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks. Lancet. 2012 Jun 30;379(9835):2439-48.

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01095796 History of Changes
Other Study ID Numbers:	GS-US-236-0102
Study First Received:	March 17, 2010
Results First Received:	September 20, 2012
Last Updated:	December 10, 2012
Health Authority:	United States: Food and Drug Administration

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