Atorvastatin for HAART Suboptimal Responders

Phase 3

Completed

• Conditions: Acquired Immune Deficiency Syndrome Virus
• Interventions: Other: atorvastatin, Lipitor®; Drug: Placebo

• Registration Number: NCT01766076
• Lead Sponsor: Makerere University

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.

Study Timeline

• Study First Submitted: 2012-12-10
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Results First Submitted: 2014-07-17
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-20
• Last Update Submitted: 2015-05-20
• Results First Posted: 2015-05-21
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
atorvastatin, Lipitor®	Placebo	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
Placebo	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
atorvastatin, Lipitor®	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
Placebo	atorvastatin, Lipitor®	Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry

Primary Outcome Measures

Name	Time	Method
Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily	12 weeks	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