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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
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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) 
[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.
Gender [1] 
[Units: Participants]
     
Female   33   40   73 
Male   159   153   312 
[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.
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
  Show All Outcome Measures

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 ]

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 ]

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 ]

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

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

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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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

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

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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

35.  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 48   [ Time Frame: Baseline, Week 48 ]

36.  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 96   [ Time Frame: Baseline, Week 96 ]

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 ]

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 ]

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 ]

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

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

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

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 ]

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 ]

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 ]

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

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

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

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

57.  Other Pre-specified:   Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96   [ Time Frame: Baseline, Week 96 ]

58.  Other Pre-specified:   Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96   [ Time Frame: Baseline, Week 96 ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

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 (89.58%)   175/193 (90.67%) 
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



  Limitations and Caveats
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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
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