Status:
COMPLETED
Backup With Combivir or Single Dose (SD) Truvada in Order to Avoid Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Resistance After SD Nevirapine for the Prevention of Mother-to-child Transmission (PMTCT)
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
University of Copenhagen
Conditions:
HIV Infections
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
The aim of the study is to find short course alternatives to single dose (sd)nevirapine for the prevention of mother-to-child HIV-transmission with the same or better degree of transmission protection...
Detailed Description
Randomised open study comparing Zidovudine from 28 weeks gestation, single dose Nevirapine + 1 week of Combivir with Zidovudine from 28 weeks gestation, single dose Nevirapine + single dose of Truvada...
Eligibility Criteria
Inclusion
- HIV infected, antiretroviral naive, not fulfilling national Tanzanian criteria for HAART treatment, giving informed consent, consenting to homevisit-follow-up in case of no-show for scheduled hospital visit.
Exclusion
- CD4 less than 350 x10(6)/L, suffering from systemic diseases in need of medical treatment e.g. TB, renal or liver failure etc.
- Creatinin higher than 1,5 mg/dL, Alanine aminotransferase above 140 U/L
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT00346567
Start Date
June 1 2006
End Date
April 1 2011
Last Update
February 23 2016
Active Locations (1)
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1
Bombo Regional Hospital
Tanga, Tanzania