NCT01766076

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 21, 2015

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

1.1 years

First QC Date

December 10, 2012

Results QC Date

July 17, 2014

Last Update Submit

May 20, 2015

Conditions

Acquired Immune Deficiency Syndrome Virus

Keywords

immune activationantiretroviral therapyatorvastatinimmune exhaustionadultsAfrica

Outcome Measures

Primary Outcomes (1)

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

    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

    12 weeks

Study Arms (2)

atorvastatin, Lipitor®

EXPERIMENTAL

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

Other: atorvastatin, Lipitor®Drug: Placebo

Placebo

PLACEBO COMPARATOR

Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry

Other: atorvastatin, Lipitor®Drug: Placebo

Interventions

atorvastatin, Lipitor®OTHER

PBMC collected for immune activation assays using flowcytometry

Also known as: Lipitor®
Placeboatorvastatin, Lipitor®
PlaceboDRUG

PBMC collected for immune activation assays using flowcytometry

Also known as: atorvastatin placebo
Placeboatorvastatin, Lipitor®

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ganesan A, Crum-Cianflone N, Higgins J, Qin J, Rehm C, Metcalf J, Brandt C, Vita J, Decker CF, Sklar P, Bavaro M, Tasker S, Follmann D, Maldarelli F. High dose atorvastatin decreases cellular markers of immune activation without affecting HIV-1 RNA levels: results of a double-blind randomized placebo controlled clinical trial. J Infect Dis. 2011 Mar 15;203(6):756-64. doi: 10.1093/infdis/jiq115. Epub 2011 Feb 15.

    PMID: 21325137BACKGROUND

  • Nakanjako D, Ssewanyana I, Mayanja-Kizza H, Kiragga A, Colebunders R, Manabe YC, Nabatanzi R, Kamya MR, Cao H. High T-cell immune activation and immune exhaustion among individuals with suboptimal CD4 recovery after 4 years of antiretroviral therapy in an African cohort. BMC Infect Dis. 2011 Feb 8;11:43. doi: 10.1186/1471-2334-11-43.

    PMID: 21299909BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Damalie Nakanjako
Organization
Makarere University
dnakanjako@gmail.com
41407000

Study Officials

  • Damalie Nakanjako, MD, PhD

    Makerere University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 10, 2012

First Posted

January 11, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

May 21, 2015

Results First Posted

May 21, 2015

Record last verified: 2015-05