NCT01766076

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Immune Deficiency Syndrome Virus

Interventions

Type	Name	Description
OTHER	atorvastatin, Lipitor®	PBMC collected for immune activation assays using flowcytometry
DRUG	Placebo	PBMC collected for immune activation assays using flowcytometry

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2013-01-11
• Last updated: 2015-05-21
• Results posted: 2015-05-21