Safety of Reduced Dose Zidovudine (AZT) Compared With Standard Dose AZT in Antiretroviral-naïve HIV-infected Patients (AZTlowdose)
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ClinicalTrials.gov Identifier: NCT01540240 |
Recruitment Status
: Unknown
Verified February 2012 by Rougemont Mathieu, University Hospital, Geneva.
Recruitment status was: Recruiting
First Posted
: February 28, 2012
Last Update Posted
: February 28, 2012
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV Zidovudine Adverse Reaction | Drug: Zidovudine | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 136 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | August 2011 |
Estimated Primary Completion Date : | December 2012 |

Arm | Intervention/treatment |
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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.
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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.
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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.
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- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540240
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 |
Cameroon | |
CNPS Hospital | Recruiting |
Yaoundé, Cameroon | |
Contact: Peter N Ngang, MD ngangbmvr@yahoo.co.uk | |
Sub-Investigator: Peter N Nchotu, MD |
Principal Investigator: | Peter N Ngang, MD | CNPS hospital, Yaoundé, Cameroun |
Responsible Party: | Rougemont Mathieu, Medical Doctor, University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT01540240 History of Changes |
Other Study ID Numbers: |
10-005 |
First Posted: | February 28, 2012 Key Record Dates |
Last Update Posted: | February 28, 2012 |
Last Verified: | February 2012 |
Keywords provided by Rougemont Mathieu, University Hospital, Geneva:
HIV treatment zidovudine dose reduction anaemia safety and efficacy comparison |
Additional relevant MeSH terms:
Zidovudine Nevirapine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |