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Atorvastatin for HAART Suboptimal Responders

Primary Purpose

Acquired Immune Deficiency Syndrome Virus

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
atorvastatin, Lipitor®
Placebo
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Immune Deficiency Syndrome Virus focused on measuring immune activation, antiretroviral therapy, atorvastatin, immune exhaustion, adults, Africa

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    atorvastatin, Lipitor®

    Placebo

    Arm Description

    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

    Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry

    Outcomes

    Primary Outcome Measures

    Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 10, 2012
    Last Updated
    May 20, 2015
    Sponsor
    Makerere University
    Collaborators
    Vaccine and Gene Therapy Institute, Florida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01766076
    Brief Title
    Atorvastatin for HAART Suboptimal Responders
    Official Title
    Use of Atorvastatin as Adjuvant Therapy Among Suboptimal Responders to Antiretroviral Therapy in an African Cohort of HAART-treated Adults: A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Makerere University
    Collaborators
    Vaccine and Gene Therapy Institute, Florida

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acquired Immune Deficiency Syndrome Virus
    Keywords
    immune activation, antiretroviral therapy, atorvastatin, immune exhaustion, adults, Africa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    Care ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    atorvastatin, Lipitor®
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry
    Intervention Type
    Other
    Intervention Name(s)
    atorvastatin, Lipitor®
    Other Intervention Name(s)
    Lipitor®
    Intervention Description
    PBMC collected for immune activation assays using flowcytometry
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    atorvastatin placebo
    Intervention Description
    PBMC collected for immune activation assays using flowcytometry
    Primary Outcome Measure Information:
    Title
    Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily
    Description
    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
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Damalie Nakanjako, MD, PhD
    Organizational Affiliation
    Makerere University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21325137
    Citation
    Ganesan A, Crum-Cianflone N, Higgins J, Qin J, Rehm C, Metcalf J, Brandt C, Vita J, Decker CF, Sklar P, Bavaro M, Tasker S, Follmann D, Maldarelli F. High dose atorvastatin decreases cellular markers of immune activation without affecting HIV-1 RNA levels: results of a double-blind randomized placebo controlled clinical trial. J Infect Dis. 2011 Mar 15;203(6):756-64. doi: 10.1093/infdis/jiq115. Epub 2011 Feb 15.
    Results Reference
    background
    PubMed Identifier
    21299909
    Citation
    Nakanjako D, Ssewanyana I, Mayanja-Kizza H, Kiragga A, Colebunders R, Manabe YC, Nabatanzi R, Kamya MR, Cao H. High T-cell immune activation and immune exhaustion among individuals with suboptimal CD4 recovery after 4 years of antiretroviral therapy in an African cohort. BMC Infect Dis. 2011 Feb 8;11:43. doi: 10.1186/1471-2334-11-43.
    Results Reference
    background

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    Atorvastatin for HAART Suboptimal Responders

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