Atorvastatin for HAART Suboptimal Responders

This study has been completed.
Sponsor:
Collaborator:
Vaccine and Gene Therapy Institute, Florida
Information provided by (Responsible Party):
College of Health Sciences, Makerere University
ClinicalTrials.gov Identifier:
NCT01766076
First received: December 10, 2012
Last updated: May 20, 2015
Last verified: May 2015

December 10, 2012
May 20, 2015
January 2013
February 2014   (final data collection date for primary outcome measure)
Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Immune activation was measured by co-expression of CD38 and HLADR on CD4 T-cells (CD4+CD38+HLADR+) Mean percentage change at 12 weeks was calculated
Change of immune activation levels by 25% after 12 weeks of atorvastatin 80mg daily [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Immune activation levels will be measured before and after administration of the intervention drug (atorvastatin, Lipitor®) and will be compared among patients that take drug and placebo.
Complete list of historical versions of study NCT01766076 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Atorvastatin for HAART Suboptimal Responders
Use of Atorvastatin as Adjuvant Therapy Among Suboptimal Responders to Antiretroviral Therapy in an African Cohort of HAART-treated Adults: A Randomised Controlled Trial

We hypothesise that atorvastatin changes immune activation among HAART-treated adults with suboptimal cluster cell differentiation 4 (CD4) recovery by 25%

The investigators have previously shown that up to 40% of HAART-treated adults have suboptimal CD4 recovery despite viral suppression. The investigators have also shown that immune activation and exhaustion are significantly higher among patients that do not exhibit satisfactory rise in CD4 counts despite viral suppression (suboptimal responders); when compared with their counterparts with viral suppression and satifactory CD4 count recovery (optimal responders). Given that atorvastatin changes immune activation in this pilot study, then larger studies can be done to understand its effect on CD4 count increase among suboptimal responders.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Acquired Immune Deficiency Syndrome Virus
  • Other: atorvastatin, Lipitor®
    PBMC collected for immune activation assays using flowcytometry
    Other Name: Lipitor®
  • Drug: Placebo
    PBMC collected for immune activation assays using flowcytometry
    Other Name: atorvastatin placebo
  • Experimental: atorvastatin, Lipitor®

    Intervention is be atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.

    Peripheral blood mononuclear cells (PBMC) will be collected for immune activation assays using flowcytometry

    Interventions:
    • Other: atorvastatin, Lipitor®
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry
    Interventions:
    • Other: atorvastatin, Lipitor®
    • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2014
February 2014   (final data collection date for primary outcome measure)

List of inclusion Criteria: HIV-infected adults on antiretroviral therapy for at least 6 years with sustained viral suppression (viral load<400 copies), and CD4 increase below 300 cells (difference between current and baseline CD4 count).

List of exclusion Criteria: History of an opportunistic infection within the previous six months, Pregnancy, History of myositis, History of ingestion of lipid-lowering agents at the baseline visit, Use of therapeutic agents known to have substantial drug-drug interactions with statins, and individuals on PI-containing HAART

Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Uganda
 
NCT01766076
HS1258
Yes
College of Health Sciences, Makerere University
Makerere University
Vaccine and Gene Therapy Institute, Florida
Principal Investigator: Damalie Nakanjako, MD, PhD Makerere University
Makerere University
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP