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

NCT01540240 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2012-02-28

No results posted yet for this study

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.

Conditions

  • HIV
  • Zidovudine Adverse Reaction

Interventions

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.

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.

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Peter N Ngang, MD · CNPS hospital, Yaoundé, Cameroun

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-12-31

Countries

  • Cameroon

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540240 on ClinicalTrials.gov