Study of 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:

NCT00869557

First received: March 24, 2009

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 in a total of 30 sites in the United States. The first participant was screened on 30 March 2009. The last participant visit (LPV) for the primary endpoint analysis (Week 24) was in November 2009; LPV for the Week 48 analysis was in May 2010; LPV for the Week 96 analysis was in May 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
126 participants were screened; 71 were randomized (48 to the Stribild group and 23 to the Atripla group). All randomized participants received at least 1 dose of study medication and comprised the safety and intent-to-treat (ITT) analysis sets. No site enrolled more than 7% of participants.

Reporting Groups

	Description
Stribild	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) were administered during the double-blind phase. Stribild QD was administered during the extension phase.
Atripla	Atripla (efavirenz [EFV] 150 mg/FTC 200 mg/TDF 300 mg) QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.

Participant Flow for 2 periods

Period 1: Randomized Phase

	Stribild	Atripla
STARTED	48	23
COMPLETED	45	20
NOT COMPLETED	3	3
Adverse Event	0	1
Lost to Follow-up	2	1
Withdrawal by Subject	0	1
Physician Decision	1	0

Period 2: Extension Phase

	Stribild	Atripla
STARTED	45	14 ^[1]
COMPLETED	0	0
NOT COMPLETED	45	14
Adverse Event	1	1
Physician Decision	2	0
Lost to Follow-up	0	1
Subjects Still on Study Treatment	42	12

[1]	Six participants completing randomized Atripla treatments did not enter open-label extension phase

Baseline Characteristics

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Reporting Groups

	Description
Stribild	Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
Atripla	Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
Total	Total of all reporting groups

Baseline Measures

	Stribild	Atripla	Total
Number of Participants [units: participants]	48	23	71
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	48	23	71
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	36 ± 8.9	35 ± 9.6	36 ± 9.1
Gender [units: participants]
Female	4	2	6
Male	44	21	65
Race/Ethnicity, Customized [units: participants]
American Indian or Alaska Native	1	0	1
Asian	1	0	1
Black	12	5	17
White	33	18	51
Other	1	0	1
Region of Enrollment [units: participants]
United States	48	23	71
HIV Disease Status [units: participants]
Asymptomatic	40	22	62
Symptomatic HIV Infections	5	0	5
AIDS	3	1	4
Hepatitis B Virus (HBV) Infection Status [units: participants]
Negative	48	23	71
Positive	0	0	0
Hepatitis C Virus (HCV) Infection Status [units: participants]
Negative	48	23	71
Positive	0	0	0
HIV-1 RNA Category (copies/mL) [units: participants]
≤ 100,000	37	18	55
> 100,000	11	5	16
Cluster Determinant 4 (CD4) Cell Count (/µL) [units: participants]
≤ 50	0	0	0
51 to ≤ 200	7	0	7
201 to ≤ 350	17	8	25
351 to ≤ 500	14	5	19
> 500	10	10	20

Outcome Measures

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1. Primary:

The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24 [ Time Frame: Week 24 ]

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2. Secondary:

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

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3. Secondary:

Change From Baseline in HIV-1 RNA (log_10 Copies/mL) [ Time Frame: Baseline to Weeks 24 and 48 ]

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4. Secondary:

Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24 [ Time Frame: Baseline to Week 24 ]

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5. Secondary:

Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline to Week 48 ]

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6. Secondary:

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 ]

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Serious Adverse Events

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Time Frame	Adverse events are reported for the double-blind treatment period for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (All Stribild).
Additional Description	No text entered.

Reporting Groups

	Description
Stribild	Stribild and placebo to match Atripla were administered during the double-blind phase.
Atripla	Atripla QHS and placebo to match Stribild QD were administered during the double blind phase.
All Stribild	The All Stribild safety analysis set included all participants who received at least 1 dose of Stribild in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind Stribild group while they received double-blind Stribild during the randomized phase and open-label Stribild during the extension phase; adverse events collected from the open-label Stribild extension phase only from the participants who were initially randomized to the Atripla group during the randomized phase. Adverse event data collected up to Week 96 database cut are presented in this entry.

Serious Adverse Events

	Stribild	Atripla	All Stribild
Total, serious adverse events
# participants affected / at risk	2/48 (4.17%)	1/23 (4.35%)	5/62 (8.06%)
Blood and lymphatic system disorders
Febrile neutropenia ^{† 1}
# participants affected / at risk	0/48 (0.00%)	1/23 (4.35%)	0/62 (0.00%)
General disorders
Pyrexia ^{† 1}
# participants affected / at risk	0/48 (0.00%)	1/23 (4.35%)	0/62 (0.00%)
Infections and infestations
Cellulitis of male external genital organ ^{† 1}
# participants affected / at risk	1/48 (2.08%)	0/23 (0.00%)	1/62 (1.61%)
Pneumonia ^{† 1}
# participants affected / at risk	1/48 (2.08%)	0/23 (0.00%)	1/62 (1.61%)
Staphylococcal infection ^{† 1}
# participants affected / at risk	1/48 (2.08%)	0/23 (0.00%)	1/62 (1.61%)
Vaccination site cellulitis ^{† 1}
# participants affected / at risk	0/48 (0.00%)	1/23 (4.35%)	0/62 (0.00%)
Appendicitis ^{† 1}
# participants affected / at risk	0/48 (0.00%)	0/23 (0.00%)	1/62 (1.61%)
Hepatitis C ^{† 1}
# participants affected / at risk	0/48 (0.00%)	0/23 (0.00%)	1/62 (1.61%)
Investigations
Platelet count decreased ^{† 1}
# participants affected / at risk	0/48 (0.00%)	1/23 (4.35%)	0/62 (0.00%)
White blood cell count decreased ^{† 1}
# participants affected / at risk	0/48 (0.00%)	1/23 (4.35%)	0/62 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma ^{† 1}
# participants affected / at risk	0/48 (0.00%)	1/23 (4.35%)	0/62 (0.00%)
Nervous system disorders
Peroneal nerve palsy ^{† 1}
# participants affected / at risk	0/48 (0.00%)	0/23 (0.00%)	1/62 (1.61%)

†	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:

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.

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00869557 History of Changes
Other Study ID Numbers:	GS-US-236-0104
Study First Received:	March 24, 2009
Results First Received:	September 20, 2012
Last Updated:	December 10, 2012
Health Authority:	United States: Food and Drug Administration

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