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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified February 2012 by Rougemont Mathieu, University Hospital, Geneva.
Recruitment status was: Recruiting

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 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: HIV/AIDS

Drug Information available for: Zidovudine

U.S. FDA Resources

Further study details as provided by Rougemont Mathieu, 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 ]
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 ]
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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Keywords provided by Rougemont Mathieu, University Hospital, Geneva:


HIV treatment zidovudine dose reduction anaemia safety and efficacy comparison

Additional relevant MeSH terms:


Nevirapine Zidovudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents	Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Antimetabolites

ClinicalTrials.gov processed this record on June 23, 2017

To Top