Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada 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:

NCT01106586

First received: April 14, 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: ATV/r + Truvada

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 146 sites in 16 countries. The first participant was screened on 06 April 2010. The last participant observation for the Week 48 analysis was on 13 September 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1017 subjects were screened; 715 were randomized (357 to the Stribild group and 358 to the ATV/r + Truvada group) of which 61.4% (439) had screening HIV-1 ribonucleic acid (RNA) ≤ 100,000 copies/mL. A total of 708 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) + placebos to match ATV/r + Truvada once daily (QD)
ATV/r + Truvada	Double-blind atazanavir 300 mg/ritonavir 100 mg (ATV/r) + emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (Truvada) + placebo to match Stribild QD

Participant Flow: Overall Study

	Stribild	ATV/r + Truvada
STARTED	353	355
COMPLETED	0	0
NOT COMPLETED	353	355
Adverse Event	13	18
Pregnancy	1	0
Lack of Efficacy	4	1
Physician Decision	1	3
Withdrawal by Subject	1	6
Lost to Follow-up	7	7
Participant Noncompliance	5	5
Protocol Violation	1	0
Subjects Still on Study Treatment	320	315

Baseline Characteristics

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Reporting Groups

	Description
Stribild	Double-blind Stribild + placebos to match ATV/r + Truvada QD
ATV/r + Truvada	Double-blind ATV/r + Truvada + placebo to match Stribild QD
Total	Total of all reporting groups

Baseline Measures

	Stribild	ATV/r + Truvada	Total
Number of Participants [units: participants]	353	355	708
Age [units: years] Mean ± Standard Deviation	38 ± 10.5	39 ± 9.8	38 ± 10.2
Gender [units: participants]
Female	29	39	68
Male	324	316	640
Race/Ethnicity, Customized [units: participants]
American Indian or Alaska Native	2	3	5
Asian	17	17	34
Black or African Heritage	72	47	119
Native Hawaiian or Pacific Islander	1	2	3
White	250	277	527
Other	11	9	20
Region of Enrollment [units: participants]
Portugal	1	2	3
United States	197	185	382
Thailand	7	4	11
Austria	12	8	20
United Kingdom	11	15	26
Switzerland	0	2	2
Italy	9	5	14
France	23	23	46
Mexico	3	2	5
Canada	19	22	41
Belgium	9	12	21
Australia	30	32	62
Denmark	1	2	3
Netherlands	2	4	6
Germany	29	36	65
Sweden	0	1	1
HIV Disease Status [units: participants]
Asymptomatic	285	293	578
Symptomatic HIV Infections	36	38	74
AIDS	32	24	56
Hepatitis B Virus (HBV) Infection Status [units: participants]
Negative	347	346	693
Positive	5	7	12
Indeterminate	0	1	1
Not done	1	1	2
Hepatitis C Virus (HCV) Infection Status [units: participants]
Negative	335	344	679
Positive	18	10	28
Indeterminate	0	0	0
Not done	0	1	1
HIV-1 RNA Category (copies/mL) [units: participants]
≤ 100,000	203	214	417
> 100,000	150	141	291
CD4 Cell Count (/µL) [units: participants]
≤ 50	12	5	17
51 to ≤ 200	42	34	76
201 to ≤ 350	122	124	246
351 to ≤ 500	122	122	244
> 500	55	70	125

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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Measure Type	Secondary
Measure Title	The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Measure Description	Change = Week 48 value minus baseline value.
Time Frame	Baseline to Week 48
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT analysis set. The missing = excluded (M = E) method was used in which participants with missing data were excluded from analysis.

Reporting Groups

	Description
Stribild	Double-blind Stribild + placebos to match ATV/r + Truvada QD
ATV/r + Truvada	Double-blind ATV/r + Truvada + placebo to match Stribild QD

Measured Values

	Stribild	ATV/r + Truvada
Number of Participants Analyzed [units: participants]	334	321
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 [units: cells/µL] Mean ± Standard Deviation	207 ± 164.2	211 ± 160.3

No statistical analysis provided for The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48

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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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:

DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-38.

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01106586 History of Changes
Other Study ID Numbers:	GS-US-236-0103
Study First Received:	April 14, 2010
Results First Received:	September 20, 2012
Last Updated:	December 10, 2012
Health Authority:	United States: Food and Drug Administration

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