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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000862 |
To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile to that obtained with the use of IV ZDV in ACTG 082. To evaluate the tolerance of oral ZDV in this population, defined as the ability to take oral doses and lack of vomiting within 30 minutes of receiving oral study doses.
The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that, at minimum, will approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would enable women to start an intensive ZDV regimen during early labor, even prior to reaching the hospital.
Condition | Intervention | Phase |
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HIV Infections Pregnancy |
Drug: Zidovudine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Phase I Trial of the Pharmacokinetics and Tolerance of Oral Zidovudine Administered to HIV-1 Infected Pregnant Women During Labor and Delivery |
Estimated Enrollment: | 36 |
The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that, at minimum, will approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would enable women to start an intensive ZDV regimen during early labor, even prior to reaching the hospital.
Cohort 1: Women in active labor receive 3 doses of oral ZDV 3 hours apart followed by PK sampling. After PK sampling post 3rd oral dose, or at 8 cm dilation (whichever comes first), women receive IV ZDV until delivery. The cord blood will be analyzed for serum ZDV PK levels and the infant's infection status will be determined. If the dose of ZDV is adequate to achieve targeted maternal serum drug levels in Cohort 1 and if oral dosing is tolerated in this cohort, Cohort 2 will begin enrollment. [AS PER AMENDMENT 08/03/01: Cohort 1 has been completed and only Cohort 2 is open for enrollment.] Cohort 2: [AS PER AMENDMENT 08/03/01: Women in active labor receive initial loading dose of oral ZDV, then another dose of oral ZDV 3 hours later, both doses followed by PK sampling. After PK sampling post second oral dose, or at 8 cm dilation (whichever comes first), woman receives IV ZDV until delivery. The cord blood will not be analyzed for serum ZDV PK levels and the infant's infection status will be determined.]
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
A woman may be eligible for this study if:
Exclusion Criteria
A woman will not be eligible for this study if:
United States, California | |
UCSF / Moffitt Hosp - Pediatric | |
San Francisco, California, United States, 941430105 | |
UCSD Med Ctr / Pediatrics / Clinical Sciences | |
La Jolla, California, United States, 920930672 | |
UCLA Med Ctr / Pediatric | |
Los Angeles, California, United States, 900951752 | |
Univ of California, San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Florida | |
Univ of Miami (Pediatric) | |
Miami, Florida, United States, 33161 | |
Univ of Florida Health Science Ctr / Pediatrics | |
Jacksonville, Florida, United States, 32209 | |
Univ of Miami / Jackson Memorial Hosp | |
Miami, Florida, United States, 33136 | |
United States, New Jersey | |
Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
Newark, New Jersey, United States, 071032714 | |
United States, Tennessee | |
Saint Jude Children's Research Hosp of Memphis | |
Memphis, Tennessee, United States, 381052794 | |
United States, Virginia | |
Children's Hosp of the King's Daughters | |
Norfolk, Virginia, United States, 23507 | |
Puerto Rico | |
San Juan City Hosp | |
San Juan, Puerto Rico, 009367344 |
Study Chair: | Mark Mirochnick | |
Study Chair: | Pamela Boyer |
Study ID Numbers: | PACTG 324 |
Study First Received: | November 2, 1999 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00000862 |
Health Authority: | United States: Federal Government |
Pregnancy Pregnancy Complications, Infectious Administration, Oral Zidovudine |
Delivery Labor Anti-HIV Agents |
Virus Diseases Sexually Transmitted Diseases, Viral Pregnancy Complications HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Pregnancy Complications, Infectious Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |