Atorvastatin for HAART Suboptimal Responders

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Makerere University
Sponsor:
Information provided by (Responsible Party):
Faculty of Medicine, Makerere University
ClinicalTrials.gov Identifier:
NCT01766076
First received: December 10, 2012
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

We hypothesise that atorvastatin changes immune activation among HAART-treated adults with suboptimal CD4 recovery by 25%


Condition Intervention Phase
Acquired Immune Deficiency Syndrome Virus
Other: 'atorvastatin, Lipitor®'
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Change of immune activation levels by 25% after 12 weeks of atorvastatin 80mg daily [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Immune activation levels will be measured before and after administration of the intervention drug (atorvastatin, Lipitor®) and will be compared among patients that take drug and placebo.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: atorvastatin

Intervention is be atorvastatin (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.

PBMC will be collected for immune activation assays using flowcytometry

Other: 'atorvastatin, Lipitor®'
PBMC collected for immune activation assays using flowcytometry
Placebo Comparator: 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
Drug: Placebo
PBMC collected for immune activation assays using flowcytometry

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • HIV-infected adults on antiretroviral therapy for at least 6 years with sustained viral suppression (viral load<400 copies)
  • CD4 increase below 300 cells (difference between current and baseline CD4 count).

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 Individuals on PI-containing HAART
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766076

Contacts
Contact: Damalie Nakanjako, MD, PhD +256772411273 drdamalie@yahoo.com
Contact: Isaac Ssinabulya, MD ssinabulya@yahoo.com

Locations
Uganda
Infectious Diseases Institute
Kampala, East Africa, Uganda
Sponsors and Collaborators
Makerere University
Investigators
Principal Investigator: Damalie Nakanjako, MD, PhD Makerere University
  More Information

Publications:
Responsible Party: Faculty of Medicine, Lecturer, Makerere University
ClinicalTrials.gov Identifier: NCT01766076     History of Changes
Other Study ID Numbers: HS1258
Study First Received: December 10, 2012
Last Updated: January 9, 2013
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
immune activation
antiretroviral therapy
atorvastatin
immune exhaustion
adults
Africa

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014