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Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase. ANRS 135 Primeva

NCT00424814 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-04-07

No results posted yet for this study

Summary

In the pre-partum phase the use of antiretroviral therapy for the mother during the last trimester of pregnancy is mandatory. The use of HAART during pregnancy, usually two nucleosides analogues and a protease inhibitor exposes the mother and the child to cumulate toxicities related to both families. The aim of this study is to assess the use of a boosted protease inhibitor without nucleoside analogue during the pre-partum phase for women with no indication of antiretroviral therapy for their own.

Conditions

  • HIV Infections

Interventions

DRUG

Kaletra (lopinavir/ritonavir)

(200/50 mg x2)x 2/d= 2 pills twice daily

DRUG

Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine)

Kaletra (lopinavir/ritonavir): (200/50 mg x2)x 2/d= 2 pills twice daily Combivir (zidovudine/lamivudine): (300/150mg) x 2/d=1 pill twice daily

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Roland Tubiana, MD · AP-HP Hopital Pitie salpetriere

  • Josiane Warszawski, MD · INSERM - INED Unité U822 France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-09-30
Completion
2012-11-30

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00424814 on ClinicalTrials.gov