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.: PACTR201312000661337 Date of Approval: 04/10/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title HAART study
Official scientific title COMPARISON OF THE THERAPEUTIC EFFICACY AND ADVERSE EFFECTS PROFILE OF TENOFOVIR/LAMIVUDINE AND ZIDOVUDINE/LAMIVUDINE -BASED FIXED DOSE REGIMENS IN THE TREATMENT OF ANTIRETROVIRAL (ART) ¿NAÏVE HIV/AIDS PATIENTS IN ZARIA, NIGERIA.
Brief summary describing the background and objectives of the trial Highly Active Anti-Retroviral Therapy (HAART)has made HIV become a manageable chronic disease.The therapeutic goals of ART are the production of long term virological suppression and immune reconstitution with minimal toxicities.This can only be achieved by rational choice of first line regimen.This study therefore sets out to compare the therapeutic efficacy and adverse effects profile of Tenofovir/lamivudine and Zidovudine/lamivudine in ART-naive HIV patients in Zaria
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Drugs
Anticipated trial start date 18/06/2012
Actual trial start date 18/06/2012
Anticipated date of last follow up 18/06/2013
Actual Last follow-up date 18/06/2013
Anticipated target sample size (number of participants) 198
Actual target sample size (number of participants) 196
Recruitment status Completed
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 numbers 1-198 placed in an a sealed envelop and participants pick as they come. even number denotes treatment arm A and odd numbers denote treatment arm B placed in sealed opaque envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tenofovir/lamivudine + nevirapine or efavirenz 300mg/300mg once daily + nevirapine 200mg twice daily or efavirenz 600mg once daily 6 months Antiretroviral drug 98
Control Group Zidovudine/lamivudine + Efavirenz or nevirapine Zidovudine 300mg/lamivudine 150mg twice daily + Efavirenz 600mg once daily or Nevirapine 200mg twice daily 6 months Highly active antiretroviral drug 98 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
HIV subjects who signed a written consent and satisfy the following criteria: 1. Aged ¿ 18 years 2. Had never received ART in the past either for treatment, post-exposure prophylaxis or PMTCT. 3. Had a baseline CD4 count of ¿350 cells/mm3 irrespective of WHO clinical staging; or WHO stage 3 or 4, irrespective of the CD4 count. 4. Seronegative for both HBsAg and HCV Ab. 5. Had the following baseline parameters: Hemogram ¿ 10g/dL, Platelet count ¿ 80,000/mm3, Absolute Neutrophil count ¿ 1000/mm3, Creatinine clearance ¿ 50mL/min (Cockcroft ¿Gault method), Serum Alanine transaminase level ¿ ×3 upper limit of normal. HIV positive subjects who were: 1. Aged < 18 years old 2. Have documented history of renal disease or have a baseline estimated creatinine clearance of < 50mL/min. 3. On nephrotoxic or cytotoxic drugs 4. Have documented history of liver disease or have a baseline ALT ¿ x 3 ULN 5. Subjects who have symptomatic anemia or baseline Hemogram of < 10mg/dL. 18 Year(s) 70 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 16/03/2012 ABUTH Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Zaria-Sokoto Road, Shika Zaria +234 Nigeria
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 16/03/2012 ABUTH health research and ethics committee
Ethics Committee Address
Street address City Postal code Country
zaria-sokoto road, shika Zaria +234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. To determine the proportion of patients on Tenofovir/lamivudine-arm compared to Zidovudine/lamivudine arm that had a virological response of ¿400 copies/mL in blood after 6 of HAART 6 months
Secondary Outcome 2. To determine the proportion of patients on Tenofovir/lamivudine-arm compared to Zidovudine/lamivudine-arm that had an increase in baseline CD4+ cell count of ¿25 cells/mm3 after 6 months of HAART. 6 months
Secondary Outcome 3. To determine the proportion of patients on Tenofovir/lamivudine regimen compared to that of Zidovudine/lamivudine who have adherence rate ¿ 95%. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ahmadu Bello University teaching Hospital, Zaria zaria-sokoto road, shika Zaria +234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
ABUTH PEPFER/APIN ABUTH Shika, zaria zaria +234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ABUTH zaria-sokoto road, Zaria +234 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Abdu-aguye faculty of Medicine, Kaduna State University, kaduna kaduna +234 Nigeria
habib adulrazaq Bayero university Kano kano +234 Nigeria
hassan Muktar zaria-sokoto road, shika zaria +234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph ogirima Ovosi joeovosi@hotmail.com +2348036527645 zaria-sokoto road
City Postal code Country Position/Affiliation
zaria +234 Nigeria senior registrar, Internal medicine/clinical pharmacology and therapeutics
Role Name Email Phone Street address
Public Enquiries ibrahim abdu-aguye ibraguye@yahoo.com +2348033379352 tafawa balewa road, kaduna
City Postal code Country Position/Affiliation
Kaduna +234 Nigeria professor and Dean of medicine
Role Name Email Phone Street address
Scientific Enquiries Abdulrazaq habib abdulrazq_habib@yahoo.co.uk +2348056909039 zaria-kano road
City Postal code Country Position/Affiliation
kano +234 Nigeria professor, infectious diseases and tropical medicine
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information