Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201301000445375 Date of Approval: 26/10/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Atorvastastin and HIV associated immune activation
Official scientific title Use of Atorvastatin among HAART-treated adults with suboptimal immune recovery in Uganda
Brief summary describing the background and objectives of the trial Pre-ART HIV-associated immune activation is associated with increased risk of morbidity and mortality. During HAART, immune activation persists and is associated with suboptimal immune recovery. Anti-immune activation agents may improve immune recovery. This clinical trial will determine the effect of adjuvant therapy with atorvastatin on T-cell immune activation and exhaustion among HAART-treated adults with suboptimal CD4 reconstitution despite viral suppression in an African cohort.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SAS study
Disease(s) or condition(s) being studied Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Drugs
Anticipated trial start date 10/12/2012
Actual trial start date 15/11/2012
Anticipated date of last follow up 30/12/2013
Actual Last follow-up date 24/01/2014
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
HS 1258 Uganda National Council for Science and Technology
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
Crossover: all participants receive all interventions in different sequence during study Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used) Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Atorvastatin group 80mg daily 12 weeks 15
Control Group Placebo 2 tablets daily 12 weeks 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 18years and above HAART for at least 4 years Sustained viral suppression CD4 increase below 300 (from the baseline) History of opportunistic infection in the previous 6 months Pregnancy 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/08/2012 Joint Clinical Research Center
Ethics Committee Address
Street address City Postal code Country
plot 101, lubowa, off entebbe road kampala 10005 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 25% reduction in immune activation levels using flowcytometry At start of intervention drug and after 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Infectious Diseases Institute Mulago hill road, Mulago hospital complex Kampala 22418 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Makerere University Infection and immunity Program Uganda Virus Research Institute Entebbe 49 Uganda
Canadian Grand Challenge 101 College street, suite 406 Toronto M5G1L7 Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Damalie Nakanjako Mulago hill road, Mulago hospital complex Kampala 22418 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Moses Kamya Mulago hill road, Mulago hospital complex Kampala 7072 Uganda
Rafick Sekaly Vaccine and Gene Therapy Institute Florida United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Isaac ssinabulya ssinabulyaisaac@gmail.com +256782083968 Makerere University College of Health Sciences, Mulago Hospital Complex, Department of Medicine
City Postal code Country Position/Affiliation
Kamplala 7072 Uganda Physician
Role Name Email Phone Street address
Principal Investigator Damalie Nakanjako dnakanjako@gmail.com +256772411273 Mulago hill road, Mulago Hospital Complex, infectuous Diseases Institute buidling
City Postal code Country Position/Affiliation
Kamplala 22418 Uganda Assocaiate Professor, Makerere University College of Health Sciences
REPORTING
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