Trial Outcomes & Findings for Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults (NCT NCT00869557)

NCT ID: NCT00869557

Last Updated: 2014-06-04

Results Overview

The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 24 was summarized.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Week 24

Results posted on

2014-06-04

Participant Flow

Participants were enrolled in a total of 30 sites in the United States. The first participant was screened on 30 March 2009. Last participant visit: * Primary endpoint analysis (Week 24): November 2009 * Week 48 analysis: April 2010 * Week 96 analysis: March 2011 * End of study: September 2013

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.

Participant milestones

Participant milestones
Measure	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.
Randomized Phase STARTED	48	23
Randomized Phase COMPLETED	45	21
Randomized Phase NOT COMPLETED	3	2
Extension Phase STARTED	45	14
Extension Phase COMPLETED	35	11
Extension Phase NOT COMPLETED	10	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Randomized Phase Lost to Follow-up	2	1
Randomized Phase Investigator's Discretion	1	0
Randomized Phase Withdrew Consent	0	1
Extension Phase Adverse Event	2	2
Extension Phase Lack of Efficacy	1	0
Extension Phase Lost to Follow-up	3	1
Extension Phase Investigator's Discretion	2	0
Extension Phase Withdrew Consent	2	0

Baseline Characteristics

Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stribild n=48 Participants Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.	Atripla n=23 Participants Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.	Total n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=99 Participants	23 Participants n=107 Participants	71 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	36 years STANDARD_DEVIATION 8.9 • n=99 Participants	35 years STANDARD_DEVIATION 9.6 • n=107 Participants	36 years STANDARD_DEVIATION 9.1 • n=206 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Sex: Female, Male Male	44 Participants n=99 Participants	21 Participants n=107 Participants	65 Participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Race/Ethnicity, Customized Asian	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Race/Ethnicity, Customized Black	12 participants n=99 Participants	5 participants n=107 Participants	17 participants n=206 Participants
Race/Ethnicity, Customized White	33 participants n=99 Participants	18 participants n=107 Participants	51 participants n=206 Participants
Race/Ethnicity, Customized Other	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
Region of Enrollment United States	48 participants n=99 Participants	23 participants n=107 Participants	71 participants n=206 Participants
HIV Disease Status Asymptomatic	40 participants n=99 Participants	22 participants n=107 Participants	62 participants n=206 Participants
HIV Disease Status Symptomatic HIV Infections	5 participants n=99 Participants	0 participants n=107 Participants	5 participants n=206 Participants
HIV Disease Status AIDS	3 participants n=99 Participants	1 participants n=107 Participants	4 participants n=206 Participants
Hepatitis B Virus (HBV) Infection Status Negative	48 participants n=99 Participants	23 participants n=107 Participants	71 participants n=206 Participants
Hepatitis B Virus (HBV) Infection Status Positive	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
Hepatitis C Virus (HCV) Infection Status Negative	48 participants n=99 Participants	23 participants n=107 Participants	71 participants n=206 Participants
Hepatitis C Virus (HCV) Infection Status Positive	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
HIV-1 RNA Category (copies/mL) ≤ 100,000	37 participants n=99 Participants	18 participants n=107 Participants	55 participants n=206 Participants
HIV-1 RNA Category (copies/mL) > 100,000	11 participants n=99 Participants	5 participants n=107 Participants	16 participants n=206 Participants
Cluster Determinant 4 (CD4) Cell Count (/µL) ≤ 50	0 participants n=99 Participants	0 participants n=107 Participants	0 participants n=206 Participants
Cluster Determinant 4 (CD4) Cell Count (/µL) 51 to ≤ 200	7 participants n=99 Participants	0 participants n=107 Participants	7 participants n=206 Participants
Cluster Determinant 4 (CD4) Cell Count (/µL) 201 to ≤ 350	17 participants n=99 Participants	8 participants n=107 Participants	25 participants n=206 Participants
Cluster Determinant 4 (CD4) Cell Count (/µL) 351 to ≤ 500	14 participants n=99 Participants	5 participants n=107 Participants	19 participants n=206 Participants
Cluster Determinant 4 (CD4) Cell Count (/µL) > 500	10 participants n=99 Participants	10 participants n=107 Participants	20 participants n=206 Participants

PRIMARY outcome

Timeframe: Week 24

Population: ITT analysis set (all participants who were randomized into the study and received at least 1 dose of study drug). The missing = failure (M = F) analysis method was used in which all missing data were considered as failure (HIV-1 RNA ≥ 50 copies/mL).

The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 24 was summarized.

Outcome measures

Outcome measures
Measure	Stribild n=48 Participants Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.	Atripla n=23 Participants Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24	89.6 percentage of participants	87.0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT analysis set; M = F analysis (all missing data were considered as failure \[HIV-1 RNA ≥ 50 copies/mL\]).

The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 48 was summarized.

Outcome measures

Outcome measures
Measure	Stribild n=48 Participants Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.	Atripla n=23 Participants Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48	89.6 percentage of participants	87.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Weeks 24 and 48

Population: ITT analysis set; The missing = excluded (M = E) analysis method was used in which all missing data were excluded from the analysis.

Change = Week 24 or 48 value minus baseline value

Outcome measures

Outcome measures
Measure	Stribild n=45 Participants Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.	Atripla n=21 Participants Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
Change From Baseline in HIV-1 RNA (log_10 Copies/mL) Baseline to Week 48	-2.89 log_10 copies/mL Standard Deviation 0.570	-2.71 log_10 copies/mL Standard Deviation 0.933
Change From Baseline in HIV-1 RNA (log_10 Copies/mL) Baseline to Week 24	-2.87 log_10 copies/mL Standard Deviation 0.578	-2.88 log_10 copies/mL Standard Deviation 0.586

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT analysis set. M = E analysis (all missing data were excluded from the analysis).

Change = Week 24 value minus baseline value

Outcome measures

Outcome measures
Measure	Stribild n=44 Participants Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.	Atripla n=21 Participants Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24	161 cells/µL Standard Deviation 141.1	117 cells/µL Standard Deviation 143.7

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: ITT analysis set; M = E analysis (all missing data were excluded from the analysis).

Change = Week 48 value minus baseline value

Outcome measures

Outcome measures
Measure	Stribild n=45 Participants Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.	Atripla n=21 Participants Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
Change From Baseline in CD4 Cell Count at Week 48	240 cells/µL Standard Deviation 172.8	166 cells/µL Standard Deviation 158.5

SECONDARY outcome

Timeframe: Baseline to Weeks 24 and 48

Population: ITT analysis set

The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.

Outcome measures

Outcome measures
Measure	Stribild n=48 Participants Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.	Atripla n=23 Participants Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
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 Virologic Success at Week 24	89.6 percentage of participants	87.0 percentage of participants
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 Virologic Success at Week 48	91.7 percentage of participants	82.6 percentage of participants

Adverse Events

Stribild

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

Atripla

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

All Stribild

Serious events: 9 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trial Disclosures

Gilead Sciences, Inc

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER

Measure	Stribild n=48 participants at risk Stribild and placebo to match Atripla were administered during the double-blind phase.	Atripla n=23 participants at risk Atripla QHS and placebo to match Stribild QD were administered during the double blind phase.	All Stribild n=62 participants at risk 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.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	4.3% 1/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
General disorders Pyrexia	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	4.3% 1/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Infections and infestations Cellulitis of male external genital organ	2.1% 1/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	1.6% 1/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Infections and infestations Pneumonia	2.1% 1/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	3.2% 2/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Infections and infestations Staphylococcal infection	2.1% 1/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	1.6% 1/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Infections and infestations Vaccination site cellulitis	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	4.3% 1/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Investigations Platelet count decreased	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	4.3% 1/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Investigations White blood cell count decreased	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	4.3% 1/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	4.3% 1/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Infections and infestations Appendicitis	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	4.8% 3/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Infections and infestations Hepatitis C	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	1.6% 1/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Nervous system disorders Peroneal nerve palsy	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	1.6% 1/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Infections and infestations Acute hepatitis C	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	1.6% 1/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	1.6% 1/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.
Psychiatric disorders Bipolar I disorder	0.00% 0/48 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	0.00% 0/23 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.	1.6% 1/62 • Adverse events are reported for the double-blind treatment period (up to 60 weeks) for the randomized treatment group (Stribild and Atripla), and for the double-blind and open-label period (up to 224 weeks) for the All Stribild group.