Atorvastatin for HAART Suboptimal Responders
Information source: Makerere University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acquired Immune Deficiency Syndrome Virus
Intervention: atorvastatin, LipitorĀ® (Other); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Makerere University Official(s) and/or principal investigator(s): Damalie Nakanjako, MD, PhD, Principal Investigator, Affiliation: Makerere University
Summary
We hypothesise that atorvastatin changes immune activation among HAART-treated adults with
suboptimal cluster cell differentiation 4 (CD4) recovery by 25%
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: 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. 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.
Starting date: January 2013
Last updated: May 20, 2015
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