HIV InfectionPhase 3STARNCT03037372
Statin Adjunct Therapy Among ART-treated Adults in Sub-Saharan Africa: Atorvastatin and Rosuvastatin Equivalence Trial
A Phase 3 study testing ART, Atorvastatin, ART, Rosuvastatin and ART, No statin in people with HIV Infection, run by Makerere University.
Trial summary
This study will determine whether 36 months of daily atorvastatin or rosuvastatin have equivalent effects in reduction of immune activation, inflammation and immune aging, when given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- ART, Atorvastatin, ART, Rosuvastatin and ART, No statin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 31 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-positive individuals 18 years and older, that have initiated three first-line drug highly active antiretroviral therapy within three months within the Infectious Diseases Institute HIV treatment cohort
- Individuals that provide written informed consent to participate in the clinical trial
Who cannot join
- Individuals with dyslipidemia and eligible to receive or already receiving statin therapy
- Pregnant or lactating mothers
- Individuals with another active or controlled inflammatory condition
- Individuals with deranged liver function tests 3 fold and above
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Statin Adjunct Therapy Among HAART-treated Adults in Sub-Saharan Africa: Equivalence of Atorvastatin and Rosuvastatin
This study will determine whether 36 months of daily atorvastatin or rosuvastatin have equivalent effects in reduction of immune activation, inflammation and immune aging, when given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort
Read the detailed description
This is a randomized, open-label trial
- Conditions
- HIV Infection
- Being tested
- ART, Atorvastatin, ART, Rosuvastatin, ART, No statin, Healthy-HIV-negative
- Keywords
- adults, antiretroviral therapy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART, AtorvastatinDrug
Also called Atovastatin adjunct therapy
ART, Atorvastatin
ART, RosuvastatinDrug
Also called Rosuvastatin adjunct therapy
ART, Rosuvastatin
ART, No statinDrug
Also called No statin adjunct therapy
ART, No statin
Healthy-HIV-negativeDrug
Also called HIV-negative controls
Age-matched, Healthy HIV-negative
| Study group | Role | What they receive |
|---|---|---|
| ART-Atorvastatin adjunct therapy | Experimental | ART, atorvastatin Receives: Drug: ART, Atorvastatin |
| ART-Rosuvastatin adjunct therapy | Experimental | ART, rosuvastatin Receives: Drug: ART, Rosuvastatin |
| ART-without statin adjunct therapy | Experimental | ART, no statin Receives: Drug: ART, No statin |
| Healthy-HIV-negative | Experimental | Age-matched HIV-negative, healthy volunteers from the same community Receives: Drug: Healthy-HIV-negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p<o.05)
measured by percentage of HLADR+CD38+T-cells
Measured: 12 months
Secondary outcomes (3)
Similar rate of change of immune aging markers, between ART-treated adults with and without statin (atorvastatin and rosuvastatin) adjunct therapy arms (P-value<0.05)
Measured by Percentage of CD4+ and CD8+ naive T-cells or percentage of expressing Ki67 T-cells or percentage of low CFSE+T-cells or increase in percentage of CD28-/CD57+ T-cells or percentage of individuals with low host responses to influenza vaccine among HIV-infected adults at ART initiation
Measured: 36 months
Similar rate of reduction of inflammatory markers, between atorvastatin and rosuvastatin arms (p<0.05)
Measured by levels of IL6 in pg/ml, hsCRP in pg/ml, d-dimers in pg/ml, IFABP in pg/ml, and LPS in pg/ml
Measured: 36 months
Biological pathways affected by atorvastatin and rosuvastatin
number of genes down-regulated by either atorvastatin or rosuvastatin
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start1 Jun 2017 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Case Western Reserve University
- Responsible party
- Sponsor
- Investigators
- Damalie Nakanjako, PhD, Principal investigator, Makerere University College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037372
- Sponsor's protocol ID
- DN2017
- Acronym
- STAR
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with the Infectious Diseases Institute, according to the IDI data sharing policy
Publications
Funderburg NT, Jiang Y, Debanne SM, Labbato D, Juchnowski S, Ferrari B, Clagett B, Robinson J, Lederman MM, McComsey GA. Rosuvastatin reduces vascular inflammation and T-cell and monocyte activation in HIV-infected subjects on antiretroviral therapy. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):396-404. doi: 10.1097/QAI.0000000000000478.
PubMed 25514794Nakanjako D, Ssinabulya I, Nabatanzi R, Bayigga L, Kiragga A, Joloba M, Kaleebu P, Kambugu AD, Kamya MR, Sekaly R, Elliott A, Mayanja-Kizza H. Atorvastatin reduces T-cell activation and exhaustion among HIV-infected cART-treated suboptimal immune responders in Uganda: a randomised crossover placebo-controlled trial. Trop Med Int Health. 2015 Mar;20(3):380-90. doi: 10.1111/tmi.12442. Epub 2015 Jan 6.
PubMed 25441397
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Adjunct Therapy Among HAART-treated Adults in Sub-Saharan Africa: Equivalence of Atorvastatin and Rosuvastatin
- ClinicalTrials.gov ID
- NCT03037372
- Acronym / sponsor ID
- STAR / DN2017
- Conditions
- HIV Infection
- Keywords
- adults, antiretroviral therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- University of Oxford, Case Western Reserve University
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether 36 months of daily atorvastatin or rosuvastatin have equivalent effects in reduction of immune activation, inflammation and immune aging, when given as adjunct therapy among patients receiving antiretroviral therapy in an African cohort
Detailed description
This is a randomized, open-label trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ART-Atorvastatin adjunct therapy | Experimental | Drug: ART, AtorvastatinART, atorvastatin |
| ART-Rosuvastatin adjunct therapy | Experimental | Drug: ART, RosuvastatinART, rosuvastatin |
| ART-without statin adjunct therapy | Experimental | Drug: ART, No statinART, no statin |
| Healthy-HIV-negative | Experimental | Drug: Healthy-HIV-negativeAge-matched HIV-negative, healthy volunteers from the same community |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV-positive individuals 18 years and older, that have initiated three first-line drug highly active antiretroviral therapy within three months within the Infectious Diseases Institute HIV treatment cohort
- Individuals that provide written informed consent to participate in the clinical trial
Key exclusion criteria (4 listed)
- Individuals with dyslipidemia and eligible to receive or already receiving statin therapy
- Pregnant or lactating mothers
- Individuals with another active or controlled inflammatory condition
- Individuals with deranged liver function tests 3 fold and above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ART, AtorvastatinAlso: Atovastatin adjunct therapyART, Atorvastatin | Drug | ART-Atorvastatin adjunct therapy |
| ART, RosuvastatinAlso: Rosuvastatin adjunct therapyART, Rosuvastatin | Drug | ART-Rosuvastatin adjunct therapy |
| ART, No statinAlso: No statin adjunct therapyART, No statin | Drug | ART-without statin adjunct therapy |
| Healthy-HIV-negativeAlso: HIV-negative controlsAge-matched, Healthy HIV-negative | Drug | Healthy-HIV-negative |
Primary outcome
Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p<o.05)
Time frame: 12 months
measured by percentage of HLADR+CD38+T-cells
3 secondary outcomes
Similar rate of change of immune aging markers, between ART-treated adults with and without statin (atorvastatin and rosuvastatin) adjunct therapy arms (P-value<0.05)
Time frame: 36 months
Similar rate of reduction of inflammatory markers, between atorvastatin and rosuvastatin arms (p<0.05)
Time frame: 36 months
Biological pathways affected by atorvastatin and rosuvastatin
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Results publication: PubMed 25514794Funderburg NT, Jiang Y, Debanne SM, Labbato D, Juchnowski S, Ferrari B, Clagett B, Robinson J, Lederman MM, McComsey GA. Rosuvastatin reduces vascular inflammation and T-cell and monocyte activation in HIV-infected subjects on antiretroviral therapy. J Acquir Immune Defic Syndr. 2015 Apr 1;68(4):396-404. doi: 10.1097/QAI.0000000000000478.
- Results publication: PubMed 25441397Nakanjako D, Ssinabulya I, Nabatanzi R, Bayigga L, Kiragga A, Joloba M, Kaleebu P, Kambugu AD, Kamya MR, Sekaly R, Elliott A, Mayanja-Kizza H. Atorvastatin reduces T-cell activation and exhaustion among HIV-infected cART-treated suboptimal immune responders in Uganda: a randomised crossover placebo-controlled trial. Trop Med Int Health. 2015 Mar;20(3):380-90. doi: 10.1111/tmi.12442. Epub 2015 Jan 6.
- Individual participant dataSharing planned: Yes. Data will be shared with the Infectious Diseases Institute, according to the IDI data sharing policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damalie Nakanjako, PhD principal investigator
Makerere University College of Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ART, Atorvastatin, ART, Rosuvastatin and ART, No statin in people with HIV Infection, run by Makerere University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damalie Nakanjako, PhD (+256772411273, dnakanjako@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Similar rate of reduction of immune activation between atorvastatin and rosuvastatin arms (p<o.05) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03037372, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.