CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 19 enrolled
Drug / intervention
Abacavir sulfate, lamivudine, and zidovudine +2 moredrug
Likely dose
Not stated in 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/NCT00086359
NCT00086359Phase 3Completed
CompareCT.gov

A Phase III Randomized Trial of the Safety and Antiretroviral Effects of Zidovudine/Lamivudine/Abacavir Versus Zidovudine/Lamivudine/Lopinavir/Ritonavir in the Prevention of Perinatal Transmission of HIV

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 1, 2004·Updated Nov 1, 2021

In Brief

A Phase 3 clinical trial evaluating Abacavir sulfate, lamivudine, and zidovudine, Lamivudine/zidovudine, and 1 other intervention for HIV Infections. Completed, enrolled 19 participants across 8 sites in 2 countries.

Detailed Summary

Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the risk of passing HIV to their infants. This study will compare how well two different combinations of anti-HIV medications control HIV in pregnancy, and whether these combinations of drugs are effective in preventing HIV from being transmitted from a pregnant woman to her baby. The two combinations are abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) and zidovudine/lamivudine (ZDV/3TC) plus lopinavir/ritonavir (LPV/RTV).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 1, 2004
Enrollment StartJul 1, 2004
Study CompletionSep 1, 2007
TodayJul 2, 2026
Posted 22.0 years ago

Interventions

Abacavir sulfate, lamivudine, and zidovudinedrug

one pill twice daily

Lamivudine/zidovudinedrug

one pill twice daily

Lopinavir/ritonavirdrug

four pills twice daily