Status:
COMPLETED
Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 f...
Detailed Description
Rates of MTCT of HIV have dramatically decreased in resource-rich countries since the introduction of antiretroviral (ARV) prophylaxis; increased prenatal care, HIV testing, and counseling; elective c...
Eligibility Criteria
Inclusion
- 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.)
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00120471
Start Date
November 1 2006
End Date
December 1 2011
Last Update
November 1 2021
Active Locations (5)
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1
Federal Univ. of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
2
Hospital Nossa Senhora da Conceicao CRS
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
3
Irmandade Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
4
HSE-Hospital dos Servidores do Estado CRS
Rio de Janeiro, Brazil, 20221-903