Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108587192356 Date of Approval: 25/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The interaction of Antiretroviral Drugs with the Microbiome
Official scientific title The interaction of Antiretroviral Drugs with the Microbiome: Implications on the development of cardiovascular diseases in HIV+ persons
Brief summary describing the background and objectives of the trial The longevity of people living with HIV has been enhanced by the introduction of antiretroviral (ARV) drugs in the mid-90s. Antiretroviral therapy (ART) is now mandatory for all persons who test HIV positive in South Africa and the government policy is to start treatment upon diagnosis. The ART is based on protease inhibitors (PIs) and nucleoside reverse transcriptase inhibitors (NRTIs) and both groups of drugs have been reported to have deleterious side effects manifesting as HIV-associated lipodystrophy syndrome, metabolic syndrome, and cardiovascular diseases. HIV infection also causes dislocation of the gut microbiota which also contributes towards the observed systemic inflammation even before patients are on ART. The aim of this study is to find the relationship between HIV infection, ART, endothelial function, and gut microbial dynamics and how they influence the development of cardiovascular disease (CVD) and metabolic syndrome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ADMIC
Disease(s) or condition(s) being studied Circulatory System,Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 13/08/2020
Actual trial start date 16/08/2021
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 31/12/2021
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ART Standard treatment chronic medication follow up on participants recently diagnosed to assess gut microbial dynamics and blood chemistry changes at 6 monthly intervals 300
Control Group No intervention No treatment. sample collection at similar intervals as the experimental group 24 months NA 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. 60>Age ≧18 years at the time of signing a consent form 2. Signed consent form 3. Resident of Mthatha and surrounding rural areas for the past 12 months 4. Have received counseling pre – and post-testing for HIV 5. Reports overnight fast 1. Use of antibiotics 2. Antidiabetic medication 3. Gastrointestinal disease 4. Smoking 5. Tested COVID19 positive in the three months prior to the data collection Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/12/2020 WSU Faculty of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Sisson Street Mthatha 5100 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quantify and characterise HIV related gut microbial shift and vascular function and how this is modulated by ART. 0, 6, 12, 18, 24 months
Secondary Outcome 2. Improved HIV/AIDS & COVID19 awareness in the study community 0, 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mthatha Gateway Clinic Nelson Mandela Drive Mthatha 5100 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Foundation Meiring Naude Road Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor WSU Nelson Mandela Drive Mthatha 5100 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Nandu Goswami Gravitational Physiology and Medicine Research Unit, Institute of Physiology, Medical University of Graz Graz A-8010 Austria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hannibal Musarurwa hmusarurwa@wsu.ac.za 0027646548739 Nelson Mandela Drive
City Postal code Country Position/Affiliation
Mthatha 5100 South Africa PI
Role Name Email Phone Street address
Public Enquiries Odwa Shibe oshibe@wsu.ac.za 0026475022352 Nelson Mandela Drive
City Postal code Country Position/Affiliation
Mthatha South Africa Secretary
Role Name Email Phone Street address
Scientific Enquiries Nandu Goswami nandu.goswami@medunigraz.at 00436647924948 Graz Medical University
City Postal code Country Position/Affiliation
Graz A-8010 Austria CoPI
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participant data will only be used for research purposes and their identities will remain anonymous. A participant will be allowed access to his/her data only if he indicates from the onset that he would like to know the results of laboratory analysis. During analysis names and participants, IDs will not be used unless their use is pertinent for the analysis. Sequence data from the next-generation sequencing will be deposited in the NCBI database Study Protocol 12 months after study PIs; Research students
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information