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Phase 2 N=730 Randomized Double-blind Prevention

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

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00270296 ↗
Enrolled (actual)
730
Serious AEs
16.7%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Virologic Suppression — 274; 256; 160 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Trizivir (Drug); Lamivudine/Zidovudine (Drug); Lopinavir/Ritonavir (Drug); Nevirapine (Drug)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
Mar 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Virologic Suppression		 274; 256; 160 —
PRIMARY
Number of HIV+ Infants		 6; 1; 1 —

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.

Eligibility Criteria

Inclusion Criteria for Mothers:

  • HIV-infected
  • At least at 26th week of pregnancy (treatment group) or 18th week of pregnancy (observational group) but not beyond the 34th week of pregnancy
  • Able to complete study visits until at least 6 months postpartum
  • Citizen of Botswana

Exclusion Criteria for Mothers:

  • Taken ARVs for more than 1 week, other than ZDV, during current or prior pregnancy. Women who have received single-dose NVP in a prior pregnancy are not excluded.
  • Certain abnormal laboratory values
  • Plan to formula feed
  • Known fetal abnormalities that suggest the fetus will not survive to 6 months of gestational age
  • Known allergy or medical contraindication to any of the study drugs
  • Require certain medications
  • Previous participation in the "Prevention of Milk-Borne Transmission of HIV-1C in Botswana" (Mashi) study
  • Currently incarcerated
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00270296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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