Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Rigshospitalet, Denmark University of Copenhagen |
---|---|
Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00346567 |
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: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 450 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
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) |
2: Experimental
AZT from week 28 or asap thereafter. Intrapartum Single dose Truvada + Single dose NVP
|
Drug: Emtricitabine and Tenofovir (Truvada) |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Terese L Katzenstein, MD, Ph.D. | +45 35 45 14 92 | katzenstein@dadlnet.dk |
Contact: Jan Gerstoft, M.D. DMSc. | + 45 35 45 77 44 | gerstoft@rh.dk |
Tanzania | |
Bombo Regional Hospital | Recruiting |
Tanga, Tanzania | |
Sub-Investigator: Martha Lemnge, Ph.D. | |
Principal Investigator: Mercy G Chiduo, MD |
Study Director: | Terese L Katzenstein, MD Ph.D. | Rigshospitalet, Copenhagen, Denmark |
Responsible Party: | Rigshospitalet ( Terese Katzenstein Consultant, MD, Ph.D. DMSc ) |
Study ID Numbers: | comtru |
Study First Received: | June 29, 2006 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00346567 History of Changes |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
mother-to-child-transmission PMTCT HIV resistance NNRTI |
Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases |
Nevirapine Anti-Retroviral Agents Emtricitabine HIV Infections Sexually Transmitted Diseases Tenofovir Retroviridae Infections Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents Emtricitabine HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |