KIVEXA Vs TRUVADA, Both Administered With Efavirenz, In ART-Naive Subjects (ASSERT)

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00549198

First received: October 24, 2007

Last updated: April 7, 2011

Last verified: April 2011

History of Changes

Results First Received: September 23, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Infection, Human Immunodeficiency Virus I HIV Infection
Interventions:	Drug: Abacavir/lamivudine and efavirenz Drug: Tenofovir/Emtricitabine and efavirenz

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
ABC/3TC FDC	Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC	Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Participant Flow: Overall Study

	ABC/3TC FDC	TDF/FTC FDC
STARTED	195 ^[1]	197 ^[2]
COMPLETED	115	134
NOT COMPLETED	80	63
Adverse Event	28	26
Insufficient Viral Load Response	4	2
Protocol-defined Virological Failure	7	0
Non-compliance	2	4
Lost to Follow-up	7	8
Treatment Eligibility Criteria Not Met	3	0
Protocol Violation	7	2
Investigator Decision	4	3
Withdrawal by Subject	7	7
Disease Progression	1	0
Participant Moved	2	0
Participant not able to perform Week 96	1	0
Participant moved.Week 96 visit, no scan	1	0
Prohibited Medication	1	2
Participant planning pregnancy	1	0
Participant overweight, no scan possible	1	0
No scan facilities	0	2
Pregnancy	0	3
Not Exposed to Study Drug	3	4

[1]	Three participants were randomized but were not exposed to study drug (ABC/3TC).
[2]	Four participants were randomized but were not exposed to study drug (TDF/FTC).

Baseline Characteristics

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Reporting Groups

	Description
ABC/3TC FDC	Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC	Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
Total	Total of all reporting groups

Baseline Measures

	ABC/3TC FDC	TDF/FTC FDC	Total
Number of Participants [units: participants]	192	193	385
Age ^[1] [units: Years] Median ( Full Range )	38.0 ( 19 to 70 )	36.0 ( 18 to 66 )	37.0 ( 18 to 70 )
Gender ^[1] [units: Participants]
Female	33	40	73
Male	159	153	312
Race/Ethnicity, Customized ^[1] [units: participants]
African American/African Heritage	26	30	56
American Indian or Alaska Native	11	7	18
Asian	2	5	7
White	153	151	304

[1]	The Intent-to-Treat (ITT)-Exposed (E) Population, comprised of all randomized participants who received at least one dose of study medication, was used for all baseline characteristics.

Outcome Measures

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1. Primary:

Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48 [ Time Frame: Baseline, Week 48 ]

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2. Secondary:

Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24 [ Time Frame: Baseline, Week 24 ]

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3. Secondary:

Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96 [ Time Frame: Baseline, Week 96 ]

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4. Secondary:

Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24 [ Time Frame: Baseline, Week 24 ]

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5. Secondary:

Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48 [ Time Frame: Baseline, Week 48 ]

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6. Secondary:

Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96 [ Time Frame: Baseline, Week 96 ]

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7. Secondary:

Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 [ Time Frame: Baseline, Week 24 ]

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8. Secondary:

Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 [ Time Frame: Baseline, Week 48 ]

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9. Secondary:

Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 [ Time Frame: Baseline, Week 96 ]

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10. Secondary:

Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 [ Time Frame: Baseline, Week 24 ]

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11. Secondary:

Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 [ Time Frame: Baseline, Week 48 ]

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12. Secondary:

Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 [ Time Frame: Baseline, Week 96 ]

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13. Secondary:

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 [ Time Frame: Baseline, Week 24 ]

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14. Secondary:

Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 [ Time Frame: Baseline, Week 24 ]

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15. Secondary:

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 [ Time Frame: Baseline, Week 48 ]

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16. Secondary:

Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 [ Time Frame: Baseline, Week 48 ]

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17. Secondary:

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 [ Time Frame: Baseline, Week 96 ]

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18. Secondary:

Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 [ Time Frame: Baseline, Week 96 ]

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19. Secondary:

Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 [ Time Frame: Baseline, Week 24 ]

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20. Secondary:

Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 [ Time Frame: Baseline, Week 48 ]

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21. Secondary:

Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 [ Time Frame: Baseline, Week 96 ]

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22. Secondary:

Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 [ Time Frame: Week 24 ]

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23. Secondary:

Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 [ Time Frame: Week 48 ]

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24. Secondary:

Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 [ Time Frame: Week 96 ]

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25. Secondary:

Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 [ Time Frame: Baseline to Week 24 ]

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26. Secondary:

Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 [ Time Frame: Baseline to Week 48 ]

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27. Secondary:

Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 [ Time Frame: Baseline to Week 96 ]

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28. Secondary:

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 [ Time Frame: Baseline, Week 24 ]

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29. Secondary:

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 [ Time Frame: Baseline, Week 48 ]

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30. Secondary:

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 [ Time Frame: Baseline, Week 96 ]

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31. Secondary:

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 [ Time Frame: Baseline, Week 24 ]

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32. Secondary:

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 [ Time Frame: Baseline, Week 48 ]

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33. Secondary:

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 [ Time Frame: Baseline, Week 96 ]

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34. Secondary:

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 [ Time Frame: Baseline, Week 24 ]

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35. Secondary:

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36. Secondary:

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37. Secondary:

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 [ Time Frame: Baseline, Week 24 ]

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38. Secondary:

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 [ Time Frame: Baseline, Week 48 ]

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39. Secondary:

Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 [ Time Frame: Baseline, Week 96 ]

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40. Secondary:

Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 [ Time Frame: Week 24 ]

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41. Secondary:

Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 [ Time Frame: Week 48 ]

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42. Secondary:

Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 [ Time Frame: Week 96 ]

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43. Secondary:

Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 [ Time Frame: Week 24 ]

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44. Secondary:

Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 [ Time Frame: Week 48 ]

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45. Secondary:

Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 [ Time Frame: Week 96 ]

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46. Secondary:

Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24 [ Time Frame: Baseline, Week 24 ]

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47. Secondary:

Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48 [ Time Frame: Baseline, Week 48 ]

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48. Secondary:

Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96 [ Time Frame: Baseline, Week 96 ]

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49. Secondary:

Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 [ Time Frame: Week 96 ]

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50. Secondary:

Number of Participants Who Indicated "Yes" or "No" to the Question of Whether Unplanned Healthcare Resources Were Utilized [ Time Frame: Baseline to Week 96 ]

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51. Other Pre-specified:

Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96 [ Time Frame: Baseline, Week 96 ]

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52. Other Pre-specified:

Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96 [ Time Frame: Baseline, Week 96 ]

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53. Other Pre-specified:

Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96 [ Time Frame: Baseline, Week 96 ]

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54. Other Pre-specified:

Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96 [ Time Frame: Baseline, Week 96 ]

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55. Other Pre-specified:

Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96 [ Time Frame: Baseline, Week 96 ]

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56. Other Pre-specified:

Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96 [ Time Frame: Baseline, Week 96 ]

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57. Other Pre-specified:

Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96 [ Time Frame: Baseline, Week 96 ]

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58. Other Pre-specified:

Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96 [ Time Frame: Baseline, Week 96 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	Serious adverse events (SAEs) and adverse events (AEs) were collected in the Safety Population, comprised of all randomized participants who received at least one dose of study medication.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
ABC/3TC FDC	Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
TDF/FTC FDC	Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD

Other Adverse Events

	ABC/3TC FDC	TDF/FTC FDC
Total, other (not including serious) adverse events
# participants affected / at risk	172/192	175/193
Gastrointestinal disorders
Diarrhoea ^{† 1}
# participants affected / at risk	36/192 (18.75%)	27/193 (13.99%)
Nausea ^{† 1}
# participants affected / at risk	17/192 (8.85%)	16/193 (8.29%)
Vomiting ^{† 1}
# participants affected / at risk	12/192 (6.25%)	11/193 (5.70%)
General disorders
Fatigue ^{† 1}
# participants affected / at risk	14/192 (7.29%)	16/193 (8.29%)
Infections and infestations
Nasopharyngitis ^{† 1}
# participants affected / at risk	39/192 (20.31%)	36/193 (18.65%)
Influenza ^{† 1}
# participants affected / at risk	12/192 (6.25%)	14/193 (7.25%)
Investigations
Bone density decreased ^{† 1}
# participants affected / at risk	5/192 (2.60%)	15/193 (7.77%)
Musculoskeletal and connective tissue disorders
Back pain ^{† 1}
# participants affected / at risk	11/192 (5.73%)	16/193 (8.29%)
Nervous system disorders
Dizziness ^{† 1}
# participants affected / at risk	48/192 (25.00%)	48/193 (24.87%)
Headache ^{† 1}
# participants affected / at risk	17/192 (8.85%)	29/193 (15.03%)
Psychiatric disorders
Abnormal dreams ^{† 1}
# participants affected / at risk	23/192 (11.98%)	22/193 (11.40%)
Insomnia ^{† 1}
# participants affected / at risk	21/192 (10.94%)	18/193 (9.33%)
Sleep disorder ^{† 1}
# participants affected / at risk	14/192 (7.29%)	16/193 (8.29%)
Depression ^{† 1}
# participants affected / at risk	14/192 (7.29%)	15/193 (7.77%)
Respiratory, thoracic and mediastinal disorders
Cough ^{† 1}
# participants affected / at risk	17/192 (8.85%)	13/193 (6.74%)
Skin and subcutaneous tissue disorders
Rash ^{† 1}
# participants affected / at risk	18/192 (9.38%)	20/193 (10.36%)

†	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
No text entered.

Results Point of Contact:

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

Publications:

Post FA, Moyle GJ, Stellbrink HJ, et al. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. [JAIDS]. 2010;55(1):49-57.

Molina JM, Andrade-Villanueva J, Echevarria J, Chetchotisakd P, Corral J, David N, Moyle G, Mancini M, Percival L, Yang R, Wirtz V, Lataillade M, Absalon J, McGrath D; CASTLE Study Team. Once-daily atazanavir/ritonavir compared with twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010 Mar 1;53(3):323-32.

Publications automatically indexed to this study:

Post FA, Moyle GJ, Stellbrink HJ, Domingo P, Podzamczer D, Fisher M, Norden AG, Cavassini M, Rieger A, Khuong-Josses MA, Branco T, Pearce HC, Givens N, Vavro C, Lim ML. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr. 2010 Sep 1;55(1):49-57.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00549198 History of Changes
Other Study ID Numbers:	CNA109586
Study First Received:	October 24, 2007
Results First Received:	September 23, 2010
Last Updated:	April 7, 2011
Health Authority:	Austria: Agency for Health and Food Safety Germany: Federal Institute for Drugs and Medical Devices Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

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