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| Descriptive Information Fields | |||||||||
| Brief Title † | Backup With Combivir or Single Dose (Sd) Truvada in Order to Avoid NNRTI Resistance After Sd Nevirapine for the PMTCT | ||||||||
| Official Title † | Clinical Trial: Backup With Combivir (AZT/3TC) or Single Dose (Sd) Truvada (FTC/TDF) in Order to Avoid NNRTI Resistance After Sd Nevirapine for the Prevention of Mother-to-Child Transmission (MTCT) | ||||||||
| 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 than sd nevirapine but with less NNRTI resistance development. |
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| Detailed Description | Randomised open study comparing single dose nevirapine + 1 week of combivir with single dose nevirapine with one dose of truvada for the mothers during birth. In both arms the infants will receive one dose of nevirapine within the first days after births. N = 300. The study will be conducted at Ngamiani and Bombo Regional Hospital in Tanga, Tanzania as a cooperation between Rigshospitalet, Denmark, University of Copenhagen and National Institute of Medical Research, Tanzania. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | frequency of mother-to-child HIV transmission frequency of NNRTI resistance development |
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| Secondary Outcome Measure † | Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia Comparison of p24 antigen ability to detect viremia for the various subtypes A,C & D |
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| Condition † | HIV | ||||||||
| Intervention † | Drug: nevirapine combivir (AZT/3TC) truvada (FTC/TDF) drugs | ||||||||
| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 300 | ||||||||
| Start Date † | June 2006 | ||||||||
| Completion Date | March 2008 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Tanzania | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00346567 | ||||||||
| Organization ID | comtru | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Rigshospitalet, Denmark | ||||||||
| Collaborators †† | University of Copenhagen | ||||||||
| Investigators † |
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| Information Provided By | Rigshospitalet, Denmark | ||||||||
| Verification Date | June 2006 | ||||||||
| First Received Date † | June 29, 2006 | ||||||||
| Last Updated Date | June 29, 2006 | ||||||||
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