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OpenTrials
Completed

NCT Number: NCT01766076

Atorvastatin for HAART Suboptimal Responders

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin, Lipitor®

Other

PBMC collected for immune activation assays using flowcytometry

Other names: Lipitor®

Placebo

Drug

PBMC collected for immune activation assays using flowcytometry

Other names: atorvastatin placebo

Primary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Collaborators

  • Vaccine and Gene Therapy Institute, Florida

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 11, 2013
Registry last updated
May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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