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Comparison of Anti-HIV Drug Combinations to Prevent Mother-to-Child Transmission of HIV

NCT00086359 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-11-01

No results posted yet for this study

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).

Conditions

  • HIV Infections

Interventions

DRUG

Abacavir sulfate, lamivudine, and zidovudine

one pill twice daily

DRUG

Lamivudine/zidovudine

one pill twice daily

DRUG

Lopinavir/ritonavir

four pills twice daily

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Andrew D. Hull, MD · Department of Reproductive Medicine, Division of Perinatal Medicine, University of California, San Diego School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Completion
2007-09-30

Countries

  • United States
  • Puerto Rico

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 NCT00086359 on ClinicalTrials.gov