Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT01252940

First received: December 1, 2010

Last updated: April 19, 2013

Last verified: April 2013

History of Changes

Results First Received: March 8, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV-1 Infection
Interventions:	Drug: FTC/RPV/TDF Drug: Baseline antiretroviral (ARV) Regimen (PI+RTV plus two NRTIs)

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 110 sites in the North America and Europe. The first participant was screened on 17 November 2010. The last participant observation for the Week 48 analysis was on 20 August 2012.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
617 participants were screened and 482 were randomized. Of those participants randomized, 476 received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.

Reporting Groups

	Description
FTC/RPV/TDF	This reporting group includes participants who switched from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
Stay on Baseline Regimen	This reporting group includes participants who stayed on their existing treatment regimen at the beginning of the study through Week 24, and who may have switched at the Week 24 visit to the FTC/RPV/TDF STR through Week 48.

Participant Flow: Overall Study

	FTC/RPV/TDF	Stay on Baseline Regimen
STARTED	321	161
Randomized and Treated	317	159
Switched Regimen (Week 24 Visit)	0	152
COMPLETED	294	146 ^[1]
NOT COMPLETED	27	15
Randomized but not treated	4	2
Adverse Event	3	4
Lack of Efficacy	1	0
Physician Decision	1	0
Withdrawal by Subject	7	5
Lost to Follow-up	6	1
Subject Non-compliance	1	1
Protocol Violation	4	2

[1]	Discontinuations after switch, withdrew from study, 2; adverse event, 4; protocol violation, 1.

Baseline Characteristics

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Reporting Groups

	Description
FTC/RPV/TDF	This reporting group includes participants who switched from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
Stay on Baseline Regimen	For the reporting of Baseline Characteristics, this group includes participants who stayed on their existing treatment regimen from the beginning of the study until Week 24, and who may have switched to the FTC/RPV/TDF STR at the Week 24 visit.
Total	Total of all reporting groups

Baseline Measures

	FTC/RPV/TDF	Stay on Baseline Regimen	Total
Number of Participants [units: participants]	317	159	476
Age [units: years] Mean ± Standard Deviation	41 ± 9.2	43 ± 9.7	42 ± 9.4
Gender [units: participants]
Female	44	15	59
Male	273	144	417
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	51	31	82
Not Hispanic or Latino	264	128	392
Unknown or Not Reported	2	0	2
Race/Ethnicity, Customized [units: participants]
White	241	124	365
Black or African American	61	22	83
American Indian or Alaska Native	3	2	5
Asian	6	2	8
Other	6	9	15
Region of Enrollment ^[1] [units: participants]
Austria	18	8	26
Belgium	15	13	28
Canada	15	10	25
France	29	14	43
Germany	31	12	43
Italy	16	10	26
Puerto Rico	16	2	18
Spain	15	5	20
United Kingdom	17	6	23
United States	149	81	230
Baseline HIV-1 RNA Category [units: participants]
< 50 Copies/mL	299	152	451
50 to < 200 Copies/mL	10	6	16
200 to < 400 Copies/mL	2	0	2
400 to < 1000 Copies/mL	2	0	2
≥ 1000 Copies/mL	4	1	5
Stratification based on antiretroviral (ARV) use [units: participants]
TDF or FTC/TDF + lopinavir (LPV)/ritonavir (RTV)	82	49	131
TDF or FTC/TDF + Other PI+RTV	178	81	259
Non-TDF-containing regimen + LPV/RTV	15	9	24
Non-TDF-containing regimen + Other PI+RTV	42	20	62

[1]	Four participants in the Switch to FTC/RPV/TDF group and 2 participants in the Stay on Baseline Regimen (SBR) group were randomized but were not treated. These subjects are included in the analysis of the baseline characteristic "Region of Enrollment" but are not included in the analysis of other baseline characteristics.

Outcome Measures

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1. Primary:

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis) [ Time Frame: Week 24 ]

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2. Secondary:

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis) [ Time Frame: Week 48 ]

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3. Secondary:

Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24 [ Time Frame: Baseline to Week 24 ]

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4. Secondary:

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

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5. Secondary:

Change From Baseline in Fasting Total Cholesterol Through Week 24 [ Time Frame: Baseline to Week 24 ]

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6. Secondary:

Change From Baseline in Fasting Total Cholesterol Through Week 48 [ Time Frame: Baseline to Week 48 ]

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7. Secondary:

Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24 [ Time Frame: Baseline to Week 24 ]

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8. Secondary:

Change From Baseline in Fasting HDL Cholesterol Through Week 48 [ Time Frame: Baseline to Week 48 ]

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9. Secondary:

Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24 [ Time Frame: Baseline to Week 24 ]

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10. Secondary:

Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48 [ Time Frame: Baseline to Week 48 ]

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11. Secondary:

Change From Baseline in Fasting Triglycerides Through Week 24 [ Time Frame: Baseline to Week 24 ]

Show Outcome Measure 11

12. Secondary:

Change From Baseline in Fasting Triglycerides Through Week 48 [ Time Frame: Baseline to 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: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01252940 History of Changes
Other Study ID Numbers:	GS-US-264-0106, 2010-023178-37
Study First Received:	December 1, 2010
Results First Received:	March 8, 2013
Last Updated:	April 19, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Belgium: Federal Agency for Medicinal Products and Health Products France: ANSM - Agence national de sécurité du médicament et des produits de santé Germany: Federal Institute for Drugs and Medical Devices Italy: Ethics Committee Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency

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