Trial Outcomes & Findings for Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients (NCT NCT01533259)

NCT ID: NCT01533259

Last Updated: 2015-01-26

Results Overview

The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 48 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2015-01-26

Participant Flow

Participants were enrolled at a total of 7 study sites in the United States. The first participant was screened on 31 January 2012. The last study visit occurred on 23 August 2013.

58 participants were screened.

Participant milestones

Measure	Stribild Switch from existing treatment regimen to Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regiment (STR) once daily for 48 weeks
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

Baseline characteristics by cohort

Measure	Stribild n=48 Participants Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
Age, Continuous	44 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White	40 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Baseline HIV-1 RNA Category < 50 copies/mL	46 participants n=5 Participants
Baseline HIV-1 RNA Category 50 to < 200 copies/mL	2 participants n=5 Participants
CD4 Cell Count	711 cells/µL STANDARD_DEVIATION 265.9 • n=5 Participants
HIV Disease Status Asymptomatic	45 participants n=5 Participants
HIV Disease Status Symptomatic HIV Infection	1 participants n=5 Participants
HIV Disease Status AIDS	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set: participants who received at least one dose of study drug and had no major protocol violations of study drug resistance at baseline.

The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

Outcome measures

Measure	Stribild n=48 Participants Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12	100.0 percentage of participants Interval 92.6 to 100.0

SECONDARY outcome

Timeframe: Up to 48 weeks plus 30 days

Population: Safety Analysis Set

This outcome measure assessed the safety and tolerability profile of Stribild. Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.

Outcome measures

Measure	Stribild n=48 Participants Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities Any AE	89.6 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities Drug-related AE	25.0 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities Grade 3 or higher AE	4.2 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities Serious AE	2.1 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities Any laboratory abnormality	91.7 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities Grade 3 or 4 laboratory abnormality	4.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 24 and 48

Population: Full Analysis Set

The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

Outcome measures

Measure	Stribild n=48 Participants Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 Week 24	100.0 percentage of participants Interval 92.6 to 100.0
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 Week 48	100.0 percentage of participants Interval 92.6 to 100.0

Adverse Events

Stribild

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stribild n=48 participants at risk Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
General disorders Chest pain	2.1% 1/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Respiratory, thoracic and mediastinal disorders Emphysema	2.1% 1/48 • Up to 48 weeks plus 30 days Safety Analysis Set

Other adverse events

Measure	Stribild n=48 participants at risk Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
Gastrointestinal disorders Diarrhoea	10.4% 5/48 • Up to 48 weeks plus 30 days Safety Analysis Set
General disorders Fatigue	10.4% 5/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Immune system disorders Seasonal Allergy	6.2% 3/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Infections and infestations Upper respiratory tract infection	20.8% 10/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Infections and infestations Influenza	8.3% 4/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Infections and infestations Folliculitis	6.2% 3/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Musculoskeletal and connective tissue disorders Back pain	6.2% 3/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Musculoskeletal and connective tissue disorders Bursitis	6.2% 3/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Nervous system disorders Headache	8.3% 4/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Nervous system disorders Hypoaesthesia	6.2% 3/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Psychiatric disorders Insomnia	12.5% 6/48 • Up to 48 weeks plus 30 days Safety Analysis Set
Psychiatric disorders Anxiety	10.4% 5/48 • Up to 48 weeks plus 30 days Safety Analysis Set

Additional Information

Clinical Trial Disclosures

Gilead Sciences, Inc.

Email: ClinicalTrialDisclosures@gilead.com

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