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)

NCT00346567 | Completed

• 1 other identifier: comtru
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

mother-to-child-transmission; PMTCT; HIV; resistance; NNRTI

Outcome Measures

Primary Outcomes (2)

• frequency of mother-to-child HIV transmission

  6 weeks post partum

• frequency of NNRTI resistance development

  6 weeks post partum

Secondary Outcomes (2)

• Comparison of p24 antigen to HIV RNA for treatment induced changes in viremia

  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

  Delivery, Day 7, Day 42 post partum, mother, Day 42 and Day 90 post partum child

Study Arms (2)

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)

Interventions

Zidovudine and Lamivudine (Combivir) DRUG

1

Emtricitabine and Tenofovir (Truvada) DRUG

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator

Study Sites (1)

Bombo Regional Hospital

Tanga, Tanzania

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Zidovudine; Lamivudine; lamivudine, zidovudine drug combination; Emtricitabine; Tenofovir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Terese L Katzenstein, MD Ph.D.

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: June 30, 2006
• Study Start: June 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2011
• Last Updated: February 23, 2016

Record last verified: 2009-02

Locations

TA (1)