Atripla to Raltegravir Switch Study for CNS Toxicity (SSAT036)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT01195467
First received: September 3, 2010
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: October 29, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infection
Intervention: Drug: Truvada/Raltegravir

  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
Single Arm 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.

Participant Flow:   Overall Study
    Single Arm  
STARTED     40  
COMPLETED     30  
NOT COMPLETED     10  



  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.
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Reporting Groups
  Description
Single Arm 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.

Baseline Measures
    Single Arm  
Number of Participants  
[units: participants]
  40  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     40  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     38  
Region of Enrollment  
[units: participants]
 
United Kingdom     40  



  Outcome Measures
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1.  Primary:   The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment   [ Time Frame: 4 weeks ]

2.  Secondary:   The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment   [ Time Frame: baseline to week 12 ]

3.  Secondary:   Change From Baseline to Week 12 in CD4+ Count After 12 Weeks of Raltegravir   [ Time Frame: baseline to week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in Fasting Lipids (Total Cholesterol and Subfractions and Triglycerides) After 4 and 12 Weeks of Raltegravir   [ Time Frame: week 4 to week 12 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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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  More Information
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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
e-mail: mark.nelson@chelwest.nhs.uk


No publications provided


Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT01195467     History of Changes
Other Study ID Numbers: SSAT 036
Study First Received: September 3, 2010
Results First Received: October 29, 2014
Last Updated: November 13, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency