Clinical trial NCT03037372: Statin Adjunct Therapy Among ART-treated Adults in Sub-Saharan Africa: Atorvastatin and Rosuvastatin Equivalence Trial
Official title: Statin Adjunct Therapy Among HAART-treated Adults in Sub-Saharan Africa: Equivalence of Atorvastatin and Rosuvastatin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infection
Keywords: adults
antiretroviral therapy
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Case Western Reserve University
First posted: 2017-01-31
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether 36 months of daily atorvastatin or rosuvastatin have equivalent effects in reduction of immune activation, inflammation and immune aging, when given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort

Detailed description: This is a randomized, open-label trial

Eligibility criteria: Inclusion Criteria:

* HIV-positive individuals 18 years and older, that have initiated three first-line drug highly active antiretroviral therapy within three months within the Infectious Diseases Institute HIV treatment cohort
* Individuals that provide written informed consent to participate in the clinical trial

Exclusion Criteria:

Individuals with dyslipidemia and eligible to receive or already receiving statin therapy

* Pregnant or lactating mothers
* Individuals with another active or controlled inflammatory condition
* Individuals with deranged liver function tests 3 fold and above

Primary outcomes:
measure: Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p<o.05)
timeFrame: 12 months
Secondary outcomes:
measure: Similar rate of change of immune aging markers, between ART-treated adults with and without statin (atorvastatin and rosuvastatin) adjunct therapy arms (P-value<0.05)
timeFrame: 36 months
measure: Similar rate of reduction of inflammatory markers, between atorvastatin and rosuvastatin arms (p<0.05)
timeFrame: 36 months
measure: Biological pathways affected by atorvastatin and rosuvastatin
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Makerere University College of Health Sciences
name: Damalie Nakanjako, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Funderburg NT, Jiang Y, Debanne SM, Labbato D, Juchnowski S, Ferrari B, Clagett B, Robinson J, Lederman MM, McComsey GA. Rosuvastatin reduces vascular inflammation and T-cell and monocyte activation in HIV-infected subjects on antiretroviral therapy. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):396-404. doi: 10.1097/QAI.0000000000000478.
citation: Nakanjako D, Ssinabulya I, Nabatanzi R, Bayigga L, Kiragga A, Joloba M, Kaleebu P, Kambugu AD, Kamya MR, Sekaly R, Elliott A, Mayanja-Kizza H. Atorvastatin reduces T-cell activation and exhaustion among HIV-infected cART-treated suboptimal immune responders in Uganda: a randomised crossover placebo-controlled trial. Trop Med Int Health. 2015 Mar;20(3):380-90. doi: 10.1111/tmi.12442. Epub 2015 Jan 6.