Safety of Reduced Dose Zidovudine (AZT) Compared With Standard Dose AZT in Antiretroviral-naïve HIV-infected Patients
AZTlowdose
1 other identifier
interventional
136
1 country
1
Brief Summary
The primary objective of the study is to compare the tolerance and safety between a low-dose Zidovudine (AZT) containing regimen (200 mg BID) and a standard dosage (300 mg BID) in HIV patients initiating a first line antiretroviral therapy. The investigators expect that the low-dose regimen will show improved tolerability and safety compared to the standard dosage, with significant reduction in number of patients experiencing a new grade 1 to 4 anaemia or increasing their anaemia grade during the first 6 months of treatment. The secondary objectives of the study is to compare the efficacy of the two dosing regimen, as measured by classical clinical and biological markers: the number of new AIDS defining illness, the mortality rate, the proportion of patients achieving virological success and the mean CD4 cell count increase from baseline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
February 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFebruary 28, 2012
February 1, 2012
1.3 years
February 22, 2012
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
New grade 1 to 4 anaemia or increasing anaemia grade in the two AZT dosing arms
Differences in proportion of patients experiencing a new grade 1 to 4 anaemia or increasing their anaemia grade between the two dosing AZT regimen during the first six months of treatment. Anaemia grade will be defined by the WHO\^grading of adverse events.
full blood count will be assessed at week 2, week 8 and week 24 of starting antiretroviral treatment
Secondary Outcomes (1)
Comparison of the immunological and virological efficacy between the two AZT dosing regimen
HIV viral load and CD4 cell count will be assessed at week 4, week 8 and week 24 of starting antiretroviral treatment
Study Arms (2)
standard dosage zidovudine
ACTIVE COMPARATORStandard AZT arm: AZT 300 mg/3TC 150 mg(Combivir 1 cap) twice a day. Nevirapine 200 mg 1 cap twice a day.
low dosage zidovudine
ACTIVE COMPARATORInterventions
Low dosage AZT arm: AZT 200 mg/3TC 150 mg(zidovudine 100 mg 2 caps/lamivudine 150 mg 1 cap) twice a day. Nevirapine 200 mg 1 cap twice a day.
Eligibility Criteria
You may qualify if:
- Medical indication to initiate cART based on local guidelines
- Provision of written, informed consent
- Adults aged more than 18 years
You may not qualify if:
- Prior cART.
- Grade 2 to 4 baseline anaemia or leucopenia/neutropenia (WHO).
- Patients unable or unwilling to provide informed consent.
- Pregnant women
- AgHBs positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CNPS Hospital
Yaoundé, Cameroon
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter N Ngang, MD
CNPS hospital, Yaoundé, Cameroun
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
February 22, 2012
First Posted
February 28, 2012
Study Start
August 1, 2011
Primary Completion
December 1, 2012
Last Updated
February 28, 2012
Record last verified: 2012-02