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Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV

NCT00270296 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2021-11-02

Study results available
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Summary

Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries. However, little is known of the effectiveness of such regimens in developing countries, such as Botswana. This study will determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV) is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected pregnant women in Botswana.

Conditions

  • HIV Infections

Interventions

DRUG

Trizivir

300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily

DRUG

Lamivudine/Zidovudine

150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily

DRUG

Lopinavir/Ritonavir

400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily

DRUG

Nevirapine

200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Roger Shapiro, MD, MPH · Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Botswana-Harvard School of Public Health Partnership for Research and Education

  • Claire Moffat, MD, MPH · Department of Immunology and Infectious Diseases, Harvard School of Public Health, Botswana-Harvard School of Public Health Partnership for Research and Education

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-03-31
Completion
2010-09-30
FDA Drug
Yes

Countries

  • Botswana

Study Locations

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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 NCT00270296 on ClinicalTrials.gov