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)
This study has been completed.
Sponsor:
Rigshospitalet, Denmark
Collaborator:
University of Copenhagen
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00346567
First received: June 29, 2006
Last updated: February 22, 2016
Last verified: February 2009
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Purpose
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 | Intervention |
|---|---|
|
HIV Infections |
Drug: Zidovudine and Lamivudine (Combivir) Drug: Emtricitabine and Tenofovir (Truvada) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by Rigshospitalet, Denmark:
Primary Outcome Measures:
- 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 ]
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 ] [ 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 ]
| Enrollment: | 566 |
| Study Start Date: | June 2006 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Drug: Zidovudine and Lamivudine (Combivir) |
|
Experimental: 2
AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP
|
Drug: Emtricitabine and Tenofovir (Truvada) |
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 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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Genders 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346567
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | Terese Katzenstein Consultant, MD, Ph.D. DMSc, Rigshospitalet |
| ClinicalTrials.gov Identifier: | NCT00346567 History of Changes |
| Other Study ID Numbers: | comtru |
| Study First Received: | June 29, 2006 |
| Last Updated: | February 22, 2016 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by Rigshospitalet, Denmark:
|
mother-to-child-transmission PMTCT HIV resistance NNRTI |
Additional relevant MeSH terms:
|
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 Zidovudine Emtricitabine Lamivudine 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 |
ClinicalTrials.gov processed this record on September 23, 2016