| June 29, 2006 |
| February 17, 2009 |
| June 2006 |
| November 2010 (final data collection date for primary outcome measure) |
- frequency of mother-to-child HIV transmission [ Time Frame: 6 weeks post partum ] [ Designated as safety issue: No ]
- frequency of NNRTI resistance development [ Time Frame: 6 weeks post partum ] [ Designated as safety issue: No ]
|
- frequency of mother-to-child HIV transmission
- frequency of NNRTI resistance development
|
| Complete list of historical versions of study NCT00346567 on ClinicalTrials.gov Archive Site |
- Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia [ Time Frame: Delivery, day 7, day 42 and month 9 post partum ] [ Designated as safety issue: No ]
- Comparison of p24 antigen ability to detect viremia for the various subtypes A,C & D [ Time Frame: Delivery, Day 7, Day 42 post partum, mother, Day 42 and Day 90 post partum child ] [ Designated as safety issue: No ]
|
- 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
|
| |
| 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) |
| 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) |
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. |
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 for the mothers during birth. In both arms the infants will receive one dose of nevirapine within the first days after births as well as 7 to 28 days Zidovudine. N = 450. The study will be conducted at Ngamiani and Makorora Health Centres and Bombo Regional Hospital in Tanga, Tanzania as a cooperation between Rigshospitalet, Denmark, University of Copenhagen and National Institute of Medical Research, Tanzania. |
| |
| Interventional |
| Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| HIV Infections |
- Drug: Zidovudine and Lamivudine (Combivir)
- Drug: Emtricitabine and Tenofovir (Truvada)
|
- Active Comparator: AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily
- Experimental: AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP
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| |
| |
| Recruiting |
| 450 |
| November 2010 |
| November 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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 Criteria:
- CD4 less than 200 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
|
| Female |
| 18 Years to 55 Years |
| No |
|
|
| Tanzania |
| |
| NCT00346567 |
| Terese Katzenstein Consultant, MD, Ph.D. DMSc, Rigshospitalet |
| comtru |
| Rigshospitalet, Denmark |
| University of Copenhagen |
| Study Director: |
Terese L Katzenstein, MD Ph.D. |
Rigshospitalet, Copenhagen, Denmark |
|
|
| Rigshospitalet, Denmark |
| February 2009 |
