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)
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| ClinicalTrials.gov Identifier: NCT00346567 |
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Recruitment Status :
Completed
First Posted : June 30, 2006
Last Update Posted : February 23, 2016
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Sponsor:
Rigshospitalet, Denmark
Collaborator:
University of Copenhagen
Information provided by:
Rigshospitalet, Denmark
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Zidovudine and Lamivudine (Combivir) Drug: Emtricitabine and Tenofovir (Truvada) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 566 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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) |
| Study Start Date : | June 2006 |
| Actual Primary Completion Date : | October 2010 |
| Actual Study Completion Date : | April 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
AZT from week 28 or asap thereafter. Intrapartum AZT and 3TC + Single dose NVP Postpartum Combivir tail for 7 days twice daily
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Drug: Zidovudine and Lamivudine (Combivir) |
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Experimental: 2
AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP
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Drug: Emtricitabine and Tenofovir (Truvada) |
Primary Outcome Measures :
- frequency of mother-to-child HIV transmission [ Time Frame: 6 weeks post partum ]
- frequency of NNRTI resistance development [ Time Frame: 6 weeks post partum ]
Secondary Outcome Measures :
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346567
Locations
| Tanzania | |
| Bombo Regional Hospital | |
| Tanga, Tanzania | |
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Copenhagen
Investigators
| Study Director: | Terese L Katzenstein, MD Ph.D. | Rigshospitalet, Denmark |
| Responsible Party: | Terese Katzenstein Consultant, MD, Ph.D. DMSc, Rigshospitalet |
| ClinicalTrials.gov Identifier: | NCT00346567 History of Changes |
| Other Study ID Numbers: |
comtru |
| First Posted: | June 30, 2006 Key Record Dates |
| Last Update Posted: | February 23, 2016 |
| Last Verified: | February 2009 |
Keywords provided by Rigshospitalet, Denmark:
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mother-to-child-transmission PMTCT HIV resistance NNRTI |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Tenofovir Lamivudine Emtricitabine Zidovudine Nevirapine |
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lamivudine, zidovudine drug combination Reverse Transcriptase Inhibitors Antiviral Agents Anti-Infective Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents Antimetabolites Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |