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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
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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

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

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

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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

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 ]
  Show Outcome Measure 9

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 ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16

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 ]
  Show Outcome Measure 17

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 ]
  Show Outcome Measure 18

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 ]
  Show Outcome Measure 19

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 ]
  Show Outcome Measure 20

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 ]
  Show Outcome Measure 21

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 ]
  Show Outcome Measure 22

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 ]
  Show Outcome Measure 23

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 ]
  Show Outcome Measure 24

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

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

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

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 ]
  Show Outcome Measure 28

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 ]
  Show Outcome Measure 29

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 ]
  Show Outcome Measure 30

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 ]
  Show Outcome Measure 31

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 ]
  Show Outcome Measure 32

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 ]
  Show Outcome Measure 33

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 ]
  Show Outcome Measure 34

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 ]
  Show Outcome Measure 35

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 ]
  Show Outcome Measure 36

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 ]
  Show Outcome Measure 37

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 ]
  Show Outcome Measure 38

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 ]
  Show Outcome Measure 39

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

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

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

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 ]
  Show Outcome Measure 43

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 ]
  Show Outcome Measure 44

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 ]
  Show Outcome Measure 45

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

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

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

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 ]
  Show Outcome Measure 49

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 ]
  Show Outcome Measure 50

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 ]
  Show Outcome Measure 51

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 ]
  Show Outcome Measure 52

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 ]
  Show Outcome Measure 53

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 ]
  Show Outcome Measure 54

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 ]
  Show Outcome Measure 55

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 ]
  Show Outcome Measure 56

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

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


  Serious Adverse Events
  Hide Serious 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.

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

Serious Adverse Events
    ABC/3TC FDC     TDF/FTC FDC  
Total, serious adverse events      
# participants affected / at risk     31/192 (16.15%)     20/193 (10.36%)  
Blood and lymphatic system disorders      
Neutropenia † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Cardiac disorders      
Acute myocardial infarction † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Congenital, familial and genetic disorders      
Porphyria non-acute † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Endocrine disorders      
Goitre † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Gastrointestinal disorders      
Abdominal hernia † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Diverticulum † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Gastritis † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Rectal haemorrhage † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
General disorders      
Pyrexia † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Hepatobiliary disorders      
Cholecystitis † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Cholelithiasis † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Cholestasis † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Cytolytic hepatitis † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Hepatitis † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Immune system disorders      
Drug hypersensitivity † 1    
# participants affected / at risk     5/192 (2.60%)     1/193 (0.52%)  
Hypersensitivity † 1    
# participants affected / at risk     3/192 (1.56%)     0/193 (0.00%)  
Immune reconstitution syndrome † 1    
# participants affected / at risk     2/192 (1.04%)     0/193 (0.00%)  
Infections and infestations      
Pneumonia † 1    
# participants affected / at risk     5/192 (2.60%)     1/193 (0.52%)  
Gastroenteritis † 1    
# participants affected / at risk     2/192 (1.04%)     0/193 (0.00%)  
Lower respiratory tract infection † 1    
# participants affected / at risk     1/192 (0.52%)     1/193 (0.52%)  
Pulmonary tuberculosis † 1    
# participants affected / at risk     1/192 (0.52%)     1/193 (0.52%)  
Abscess limb † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Endocarditis † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Erysipelas † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Eye infection toxoplasmal † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Herpes Zoster † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Scrotal abscess † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Staphylococcal abscess † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Tuberculosis † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Viral infection † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Injury, poisoning and procedural complications      
Accidental overdose † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Ankle fracture † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Forearm fracture † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Humerus fracture † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Meniscus lesion † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Investigations      
Cardiac murmur † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Metabolism and nutrition disorders      
Dehydration † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Musculoskeletal and connective tissue disorders      
Back pain † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Osteoarthritis † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Burkitt's lymphoma † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Lymphoma † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Thymoma † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Nervous system disorders      
Convulsion † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Transient ischaemic attack † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Psychiatric disorders      
Acute stress disorder † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Apathy † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Renal and urinary disorders      
Renal failure † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Reproductive system and breast disorders      
Epididymitis † 1    
# participants affected / at risk     0/192 (0.00%)     1/193 (0.52%)  
Respiratory, thoracic and mediastinal disorders      
Asthma † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
Skin and subcutaneous tissue disorders      
Rash maculo-papular † 1    
# participants affected / at risk     1/192 (0.52%)     0/193 (0.00%)  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




  Other Adverse Events
  Show Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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.

Publications automatically indexed to this study:


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