Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple yet effective treatment plan is needed. Tenofovir disoproxil fumarate (TDF) is an anti-HIV drug approved for use in the United States for the treatment of HIV infected adults. The purpose of this study is to determine the safety, tolerability, and blood levels of TDF in HIV infected pregnant women and their babies. The study will be conducted at sites in Malawi and Brazil.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH); National Institute on Drug Abuse (NIDA)
• Treatments: Tenofovir

Criteria

Inclusion Criteria for HIV Infected Pregnant Women:

• HIV-1 infected

• Intend to deliver at the study site

• Willing to be contacted or visited at home

• Willing to be admitted to and remain in the delivery facility through Day 3 postpartum (Cohort 1) or Day 7 postpartum (Cohorts 2 and 3)

Exclusion Criteria for HIV Infected Pregnant Women:

• Prior treatment with TDF

• Active opportunistic infection

• Serious bacterial infection

• Chronic malabsorption or diarrhea during the current pregnancy

• Clinically significant disease or condition that, in the opinion of the study clinician, would interfere with the study

• Known multiple gestation (twins, etc.) prior to study entry

• Participation in any other therapeutic or vaccine trial during the current pregnancy

• Use of certain medications

• Any other condition or situation that, in the opinion of the investigator, would interfere with the study

• For Cohort 4, use of atazanavir or lopinavir/ritonavir (Kaletra) within 2 weeks of anticipated delivery

Exclusion Criteria for Infants Born to HIV Infected Pregnant Women:

• Birth weight of less than 2 kg (4.4 lbs)

• Severe congenital malformation or other medical condition that may affect survival and, in the opinion of the clinician, participation in this study

• Grade 2 or higher serum creatinine level or any other Grade 3 or higher toxicity

• Part of a multiple birth (twins, etc.)