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Atripla to Raltegravir Switch Study for CNS Toxicity (SSAT036)

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ClinicalTrials.gov Identifier: NCT01195467
Recruitment Status : Completed
First Posted : September 6, 2010
Results First Posted : November 4, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infection
Intervention Drug: Truvada/Raltegravir
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm
Hide Arm/Group Description No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
Period Title: Overall Study
Started 40
Completed 30
Not Completed 10
Arm/Group Title Single Arm
Hide Arm/Group Description No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
2
   5.0%
Male
38
  95.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 40 participants
40
1.Primary Outcome
Title The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment
Hide Description To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire & CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage improvement in CNS score
26
2.Secondary Outcome
Title The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment
Hide Description

The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by :

  • Sleep questionnaire
  • CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)
Time Frame baseline to week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of improvement in sleep score
25
3.Secondary Outcome
Title Change From Baseline to Week 12 in CD4+ Count After 12 Weeks of Raltegravir
Hide Description Change from baseline to week 12 in CD4+ count after 12 weeks of raltegravir having switched from efavirenz-containing therapy
Time Frame baseline to week 12
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Proportion of Patients With Viral Load < 50 Copies/mL and <400 Copies/ml at Weeks 4 and 12 After Switching to Raltegravir
Hide Description To assess the proportion of patients with viral load < 50 copies/mL and <400 copies/ml at weeks 4 and 12 after switching to raltegravir
Time Frame week 4 to week 12
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change in Fasting Lipids (Total Cholesterol and Subfractions and Triglycerides) After 4 and 12 Weeks of Raltegravir
Hide Description To assess the change in fasting lipids (total cholesterol and subfractions and triglycerides) after 4 and 12 weeks of raltegravir
Time Frame week 4 to week 12
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Proportion of Patients With Grade 2-4 Laboratory Parameters (Excluding Lipids) After 12 Weeks of Raltegravir Compared With Baseline
Hide Description To assess the proportion of patients with grade 2-4 laboratory parameters (excluding lipids) after 12 weeks of raltegravir compared with baseline
Time Frame baseline to week 12
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Proportion of Patients With Grade 2-4 Non-CNS Adverse Events After 12 Weeks of Raltegravir Compared With Baseline
Hide Description To assess the proportion of patients with grade 2-4 non-CNS adverse events after 12 weeks of raltegravir compared with baseline
Time Frame baseline to week 12
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change From Baseline in Adherence From Baseline After 12 Weeks of Raltegravir as Measured by the Adherence Questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)
Hide Description To assess the change from baseline in adherence from baseline after 12 weeks of raltegravir as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI)
Time Frame baseline to week 12
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change From Baseline of CNS Toxicity as Measured by Hospital Anxiety and Depression (HADS) Score (Baseline vs Week 12)
Hide Description To assess the change from baseline of CNS toxicity as measured by Hospital Anxiety and Depression (HADS) score (baseline vs week 12)
Time Frame baseline to week 12
Outcome Measure Data Not Reported
Time Frame 5 months
Adverse Event Reporting Description From date of informed consent to date of follow up visit
 
Arm/Group Title Single Arm
Hide Arm/Group Description No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%) # Events
Total   4/40 (10.00%)    
Blood and lymphatic system disorders   
Thombosed haemorrhoids *  1/40 (2.50%)  1
Nervous system disorders   
Peripheral neuropathy *  1/40 (2.50%)  1
Psychiatric disorders   
Deliberate overdose *  1/40 (2.50%)  1
Renal and urinary disorders   
Groin pain *  1/40 (2.50%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm
Affected / at Risk (%) # Events
Total   8/40 (20.00%)    
Ear and labyrinth disorders   
Tinnitus *  1/40 (2.50%) 
Gastrointestinal disorders   
Diarrhoea *  1/40 (2.50%) 
Musculoskeletal and connective tissue disorders   
Bilateral Arm Pain *  1/40 (2.50%) 
Nervous system disorders   
Night Sweats *  1/40 (2.50%) 
Renal and urinary disorders   
Haematuria *  1/40 (2.50%) 
Renal Colic *  1/40 (2.50%) 
Skin and subcutaneous tissue disorders   
Ichthyosis *  1/40 (2.50%) 
Cellulitis *  1/40 (2.50%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Mark Nelson
Organization: St Stephen's AIDS Trust
Phone: 02033 ext 155610
Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT01195467     History of Changes
Other Study ID Numbers: SSAT 036
First Submitted: September 3, 2010
First Posted: September 6, 2010
Results First Submitted: October 29, 2014
Results First Posted: November 4, 2014
Last Update Posted: November 26, 2014