CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 730 enrolled
Drug / intervention
Trizivir +3 moredrug
Likely dose
Trizivir 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00270296
NCT00270296Phase 2Completed
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Lopinavir/Ritonavir/Combivir vs. Abacavir/Zidovudine/Lamivudine for Virologic Efficacy and the Prevention of Mother-to-Child HIV Transmission Among Breastfeeding Women With CD4 Counts Greater Than or Equal to 200 Cells/mm3 in Botswana

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 26, 2005·Updated Nov 2, 2021

In Brief

A Phase 2 clinical trial evaluating Trizivir, Lamivudine/Zidovudine, and 2 other interventions for HIV Infections. Completed, enrolled 730 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBotswana
CollaboratorsHarvard School of Public Health (HSPH)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 26, 2005
Enrollment StartJun 1, 2006
Primary CompletionMar 1, 2009
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.5 years ago

Interventions

Trizivirdrug

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

Lamivudine/Zidovudinedrug

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

Lopinavir/Ritonavirdrug

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

Nevirapinedrug

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