A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

ViiV Healthcare

ClinicalTrials.gov Identifier:

NCT01102972

First received: April 8, 2010

Last updated: January 24, 2013

Last verified: November 2012

History of Changes

Results First Received: November 28, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Infection, Human Immunodeficiency Virus
Interventions:	Drug: Reyataz + Norvir + Truvada Drug: Reyataz + Epzicom

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 (PAR) were recruited from 44 centers in the United States, including Puerto Rico. ATV, atazanavir; RTV, ritonavir; TDF, tenofovir; FTC, emtricitrabine; QD, once daily; HIV-RNA, human immunodeficiency virus-ribonucleic acid; c, copies; ml, milliliters; ART, antiretroviral; mg, milligrams, ABC/3TC, abacavir sulfate/lamivudine.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
HLA-B*5701-negative PAR receiving an ATV/RTV + TDF/FTC regimen QD who are virologically suppressed (plasma HIV-1 RNA <75 c/mL) and met all eligibility requirements were randomized 2:1 to receive an ART regimen of ATV 400 mg QD + ABC/3TC 600 mg/300 mg QD (simplification arm) or ATV/RTV 300 mg/100 mg QD + TDF/FTC 300 mg/200 mg QD (continuation arm).

Reporting Groups

	Description
ABC/3TC + ATV	Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV	Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Participant Flow: Overall Study

	ABC/3TC + ATV	TDF/FTC + ATV/RTV
STARTED	199 ^[1]	97 ^[1]
COMPLETED	180	88
NOT COMPLETED	19	9
Adverse Event	7	2
Lack of Efficacy	1	0
Protocol Violation	1	0
Lost to Follow-up	4	3
Investigator Discretion	1	0
Withdrawal by Subject	5	4

[1]	297 PAR enrolled. 1 PAR withdrew before taking investigational product and didn’t “start” the study.

Baseline Characteristics

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Reporting Groups

	Description
ABC/3TC + ATV	Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV	Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
Total	Total of all reporting groups

Baseline Measures

	ABC/3TC + ATV	TDF/FTC + ATV/RTV	Total
Number of Participants [units: participants]	199	97	296
Age [units: Years] Mean ± Standard Deviation	42.8 ± 9.54	42.3 ± 10.20	42.6 ± 9.74
Gender [units: Participants]
Female	44	18	62
Male	155	79	234
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	51	26	77
Not Hispanic or Latino	148	71	219
Unknown or Not Reported	0	0	0
Race/Ethnicity, Customized [units: Participants]
African American/African Heritage	65	37	102
American Indian or Alaskan Native	3	0	3
Asian - East Asian Heritage	2	0	2
Asian - South East Asian Heritage	4	1	5
Native Hawaiian or Other Pacific Islander	0	1	1
White - Arabic/North African Heritage	2	0	2
White - White/Caucasian/European Heritage	120	55	175
Mixed Race	3	3	6
Number of participants with the indicated baseline HIV-RNA level ^[1] [units: participants]
HIV-1 RNA <50	192	93	285
HIV-1 RNA 50-<75	2	2	4
HIV-1 RNA >=75	5	2	7
Number of participants with the indicated Baseline CD4+ Cell Count ^[2] [units: participants]
CD4+ cells <50	0	0	0
CD4+ cells 50-<200	14	6	20
CD4+ cells >=200	185	91	276
Number of participants with the indicated Center for Disease Control (CDC) Classification ^[3] [units: participants]
Class A: Asymptomatic/lymphadenopathy/acute HIV	136	67	203
Class B: Symptomatic, not AIDS	26	13	39
Class C: AIDS indicator conditions	37	17	54
Median Baseline CD4+ Cell Count [units: cells per cubic millimeter] Median ( Full Range )	492.0 ( 77.0 to 1196.0 )	480.0 ( 108.0 to 1479.0 )	491.5 ( 77.0 to 1479.0 )
Median Baseline HIV-1 RNA Level [units: log10 copies/mL] Median ( Full Range )	1.591 ( 1.591 to 3.900 )	1.591 ( 1.591 to 3.285 )	1.591 ( 1.591 to 3.900 )
Number of participants with the indicated Baseline Hepatitis B (HB) Status ^[4] [units: participants]
Reactive	0	0	0
Non-reactive	199	97	296
Number of participants with the indicated Baseline Hepatitis C (HC) Status ^[5] [units: participants]
Reactive	18	8	26
Non-reactive	181	89	270

[1]	HIV-1 RNA, Human Immunodeficiency Virus type 1 Ribonucleic acid. HIV-1 viral load was measured as virus copies per milliliter (mL) at baseline.
[2]	A CD4+ cell is a T lymphocyte that carries the CD4 antigen. Immunologic response was assessed by CD4+ counts, measured as the number of cells per cubic millimeter.
[3]	Acquired Immunodeficiency Syndrome (AIDS) CDC classifications are Asymptomatic, Symptomatic, or AIDS. The CDC categorization of HIV/AIDS is based on the lowest documented CD4 cell count (Class A, >=500 cells per microliter [µl]; Class B, 200-499 cells/µl; Class C, <200 cells/µl) and on previously diagnosed HIV-related conditions.
[4]	The HB surface antigen is a protein present on the surface of the hepatitis B virus (HBV). It can be detected in the blood of participants with acute and chronic HBV infections. A non-reactive test result likely means that participants are not infected with HB, but does not exclude the possibility of exposure to or infection with HB.
[5]	The HC surface antigen is a protein present on the surface of the hepatitis C virus (HCV). It can be detected in the blood of participants with acute and chronic HCV infections. A non-reactive test result likely means that participants are not infected with HC, but does not exclude the possibility of exposure to or infection with HC.

Outcome Measures

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1. Primary:

Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c)/Milliliter (mL) at the Week 24 Visit: TLOVR Analysis [ Time Frame: Week 24 ]

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2. Secondary:

Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 c/mL at the Week 24 Visit: Observed, M/D=F, and SNAPSHOT Analyses [ Time Frame: Week 24 ]

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3. Secondary:

Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: TLOVR Analysis [ Time Frame: Week 24 ]

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4. Secondary:

Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <400 c/mL at the Week 24 Visit: Observed, MD=F, and SNAPSHOT Analyses [ Time Frame: Week 24 ]

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5. Secondary:

Change From Baseline in HIV-1 RNA at Week 24 [ Time Frame: Baseline and Week 24 ]

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6. Secondary:

Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline and Week 24 ]

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7. Secondary:

Change From Baseline in Triglycerides, Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Low-density Lipoprotein (LDL) Cholesterol at Week 24 [ Time Frame: Baseline and Week 24 ]

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8. Secondary:

Number of Participants Who Met the Protocol-defined Confirmed Viral Failure Criteria Through Week 24 [ Time Frame: From Baseline to Week 24 ]

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9. Secondary:

Number of Participants Who Experienced Death and/or Disease Progression [ Time Frame: From Baseline to Week 24 ]

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10. Secondary:

Number of Confirmed Virologic Failure (VF) Participants (PAR) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease From Baseline Through Week 24 [ Time Frame: From Baseline to Week 24 ]

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11. Secondary:

Number of Confirmed Virologic Failure Participants (PAR) From Baseline Through Week 24 With the Indicated Treatment-emergent Reductions in Susceptibility to Abacavir, Lamivudine, Tenofovir, Emtricitabine, Atazanavir, or Ritonavir [ Time Frame: From Baseline to Week 24 ]

Show Outcome Measure 11

12. Secondary:

Number of Participants With the Indicated Grade 2 to Grade 4 Adverse Events (AEs) Occurring at a Frequency of >=3% in Either Treatment Group [ Time Frame: From Baseline to Week 24 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	Serious adverse events (SAEs) and non-serious AEs occurring between the date of Randomization up to Week 24 are presented in this summary.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	3%

Reporting Groups

	Description
ABC/3TC + ATV	Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
TDF/FTC + ATV/RTV	Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks

Other Adverse Events

	ABC/3TC + ATV	TDF/FTC + ATV/RTV
Total, other (not including serious) adverse events
# participants affected / at risk	100/199	34/97
Gastrointestinal disorders
Nausea ^{† 1}
# participants affected / at risk	26/199 (13.07%)	3/97 (3.09%)
Diarrhoea ^{† 1}
# participants affected / at risk	13/199 (6.53%)	3/97 (3.09%)
Abdominal pain ^{† 1}
# participants affected / at risk	6/199 (3.02%)	2/97 (2.06%)
Vomiting ^{† 1}
# participants affected / at risk	7/199 (3.52%)	0/97 (0.00%)
General disorders
Fatigue ^{† 1}
# participants affected / at risk	10/199 (5.03%)	1/97 (1.03%)
Infections and infestations
Upper respiratory tract infection ^{† 1}
# participants affected / at risk	14/199 (7.04%)	10/97 (10.31%)
Bronchitis ^{† 1}
# participants affected / at risk	9/199 (4.52%)	5/97 (5.15%)
Sinusitis ^{† 1}
# participants affected / at risk	6/199 (3.02%)	6/97 (6.19%)
Nasopharyngitis ^{† 1}
# participants affected / at risk	5/199 (2.51%)	3/97 (3.09%)
Urinary tract infection ^{† 1}
# participants affected / at risk	3/199 (1.51%)	3/97 (3.09%)
Injury, poisoning and procedural complications
Muscle strain ^{† 1}
# participants affected / at risk	2/199 (1.01%)	4/97 (4.12%)
Musculoskeletal and connective tissue disorders
Back pain ^{† 1}
# participants affected / at risk	4/199 (2.01%)	3/97 (3.09%)
Muscle spasms ^{† 1}
# participants affected / at risk	1/199 (0.50%)	3/97 (3.09%)
Nervous system disorders
Headache ^{† 1}
# participants affected / at risk	15/199 (7.54%)	5/97 (5.15%)
Dizziness ^{† 1}
# participants affected / at risk	10/199 (5.03%)	1/97 (1.03%)
Psychiatric disorders
Insomnia ^{† 1}
# participants affected / at risk	10/199 (5.03%)	2/97 (2.06%)
Depression ^{† 1}
# participants affected / at risk	8/199 (4.02%)	2/97 (2.06%)
Anxiety ^{† 1}
# participants affected / at risk	7/199 (3.52%)	2/97 (2.06%)
Renal and urinary disorders
Dysuria ^{† 1}
# participants affected / at risk	6/199 (3.02%)	0/97 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^{† 1}
# participants affected / at risk	7/199 (3.52%)	3/97 (3.09%)
Skin and subcutaneous tissue disorders
Rash ^{† 1}
# participants affected / at risk	15/199 (7.54%)	1/97 (1.03%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA

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: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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
This study consists of a 35-day Screening Period, a 48-week Treatment Period (Day 1 though Week 48), and a Follow-up Period (contact approximately 2-4 weeks after the Week 48/Withdrawal Visit). Preliminary Week 24 data are presented in this summary.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: ViiV Healthcare
phone: 866-435-7343

No publications provided

Responsible Party:	ViiV Healthcare
ClinicalTrials.gov Identifier:	NCT01102972 History of Changes
Other Study ID Numbers:	113734
Study First Received:	April 8, 2010
Results First Received:	November 28, 2012
Last Updated:	January 24, 2013
Health Authority:	United States: Food and Drug Administration

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