Overview

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

Status:
Unknown status

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

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.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

University Hospital, Geneva

Treatments:

Nevirapine
Zidovudine