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Safety of Reduced Dose Zidovudine (AZT) Compared With Standard Dose AZT in Antiretroviral-naïve HIV-infected Patients (AZTlowdose)

This study is currently recruiting participants.
Verified February 2012 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Rougemont Mathieu, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01540240
First received: February 22, 2012
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV
Zidovudine Adverse Reaction
 Drug: Zidovudine
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Reduced Dose Zidovudine (AZT) Compared With Standard Dose AZT in Antiretroviral-naïve HIV-infected Patients: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Anemia HIV/AIDS
Drug Information available for: Zidovudine
U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • New grade 1 to 4 anaemia or increasing anaemia grade in the two AZT dosing arms [ Time Frame: full blood count will be assessed at week 2, week 8 and week 24 of starting antiretroviral treatment ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Comparison of the immunological and virological efficacy between the two AZT dosing regimen [ Time Frame: HIV viral load and CD4 cell count will be assessed at week 4, week 8 and week 24 of starting antiretroviral treatment ] [ Designated as safety issue: Yes ]
    The efficacy of the two dosing regimen will be measured by: 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. Secondary variables that will compare the efficacy and safety of the two AZT dosing regimen are: the viral load decrease in log after at week 4 and 8, the proportion of patients below 50 copies/ml at week 24, the proportion of patients below 400 cop/ml at week 24, the proportion of patients experiencing anaemia and neutropenia grade 3 and 4 at week 4, 8 and 24.


Estimated Enrollment: 136
Study Start Date: August 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard dosage zidovudine
Standard AZT arm: AZT 300 mg/3TC 150 mg(Combivir 1 cap) twice a day. Nevirapine 200 mg 1 cap twice a day.
 Drug: Zidovudine
Standard AZT arm: AZT 300 mg/3TC 150 mg(Combivir 1 cap) twice a day. Nevirapine 200 mg 1 cap twice a day.
Active Comparator: low dosage zidovudine Drug: Zidovudine
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical indication to initiate cART based on local guidelines
  • Provision of written, informed consent
  • Adults aged more than 18 years

Exclusion Criteria:

  • Prior cART.
  • Grade 2 to 4 baseline anaemia or leucopenia/neutropenia (WHO).
  • Patients unable or unwilling to provide informed consent.
  • Pregnant women
  • AgHBs positive
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540240

Contacts
Contact: Alexandra Calmy, PD +41 22 37 29 242 alexandra.calmy@hcuge.ch
Contact: Mathieu Rougemont, MD +41 22 37 29 806 mathieu.rougemont@hcuge.ch

Locations
Cameroon
CNPS Hospital Recruiting
Yaoundé, Cameroon
Contact: Peter N Ngang, MD         ngangbmvr@yahoo.co.uk    
Sub-Investigator: Peter N Nchotu, MD            
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Peter N Ngang, MD CNPS hospital, Yaoundé, Cameroun
  More Information

No publications provided

Responsible Party: Rougemont Mathieu, Medical Doctor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01540240     History of Changes
Other Study ID Numbers: 10-005
Study First Received: February 22, 2012
Last Updated: February 27, 2012
Health Authority: Cameroon: Ministry of Public Health

Keywords provided by University Hospital, Geneva:
HIV treatment
zidovudine
dose reduction
anaemia
safety and efficacy comparison

Additional relevant MeSH terms:
Zidovudine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
 Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 23, 2013