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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: | NCT00000888 |
The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to their babies after birth.
Pregnant women who are HIV-positive are at risk of giving HIV to their babies during pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV infection from mother to infant but studies are needed to determine whether they are safe and effective during pregnancy.
Condition | Intervention | Phase |
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HIV Infections Pregnancy |
Drug: Ritonavir Drug: Lamivudine Drug: Zidovudine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Ritonavir Co-Administered With Lamivudine (3TC) and Zidovudine (ZDV) in HIV-1-Infected Pregnant Women and Their Infants |
Estimated Enrollment: | 14 |
Study Start Date: | December 1997 |
Controlled studies of the pharmacokinetics and safety of new drugs are critical to the development of alternative therapies for the prevention of perinatal transmission of HIV-1. The dosing regimen of RTV and ZDV used to treat pregnant women in this study has been shown to be safe and effective against HIV in adults. Little is known about the metabolism and tolerance of these drugs during pregnancy, and Phase I studies are needed to determine dosage, safety, and tolerance. Protease inhibitors in combination with other antiretroviral drugs may help reduce the rate of perinatal transmission of HIV-1.
Pregnant women start with RTV (increasing gradually over a few days) plus 3TC plus ZDV until active labor. Intrapartum, women receive RTV plus 3TC plus ZDV, then postpartum (after cord clamped until 12 weeks postpartum), RTV plus 3TC plus ZDV. [AS PER AMENDMENT 2/9/99: For maternal dosing, one Combivir tablet (containing 3TC and ZDV) may be administered in place of the individual agents 3TC and ZDV. During the intrapartum period, Combivir is held and the patient follows intrapartum 3TC/ZDV dosing. During the intrapartum period, no RTV is given after the onset of active labor. During the postpartum period, RTV is begun as soon as oral intake is allowable following delivery. During the postpartum period, Combivir may be resumed. All subjects who prematurely discontinue study treatment should continue to be followed for the duration of the study.] [AS PER AMENDMENT 9/28/99: During the intrapartum period, RTV is given at the start of active labor.] Infants begin 3TC and ZDV as soon as oral intake is tolerated. Infants participate in one of two cohorts. The first four infants delivered (Cohort 1) receive RTV as a single dose between Days 8 and 12. The next six infants delivered (Cohort 2) start RTV at 2-3 days of life. The dosing schedule is based on Cohort 1 drug pharmacokinetics data. [AS PER AMENDMENT 2/9/99: Cohort 1 is expanded to seven mother/infant pairs.] [AS PER AMENDMENT 9/28/99: Cohort 1 is expanded to eight mother/infant pairs.] Both maternal and infant blood is drawn to assess drug pharmacokinetics. Cervical secretions are collected to assess presence of virus. In addition, all placentas are examined by histopathology to determine the role of placenta on preterm delivery in women receiving combination antiretroviral therapy.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Women may be eligible for this study if they:
Exclusion Criteria
Women will not be eligible for this study if they:
United States, District of Columbia | |
Howard Univ Hosp | |
Washington, District of Columbia, United States, 20060 | |
United States, Florida | |
Univ of Miami (Pediatric) | |
Miami, Florida, United States, 33161 | |
Univ of Miami / Jackson Memorial Hosp | |
Miami, Florida, United States, 33136 | |
United States, Louisiana | |
Tulane Univ Hosp of New Orleans | |
New Orleans, Louisiana, United States, 701122699 | |
Univ Hosp | |
New Orleans, Louisiana, United States, 70112 | |
Tulane Univ / Charity Hosp of New Orleans | |
New Orleans, Louisiana, United States, 701122699 | |
United States, Michigan | |
Children's Hosp of Michigan | |
Detroit, Michigan, United States, 48201 | |
United States, Tennessee | |
Methodist Hosp Central | |
Memphis, Tennessee, United States, 381052794 | |
Saint Jude Children's Research Hosp of Memphis | |
Memphis, Tennessee, United States, 381052794 | |
Regional Med Ctr at Memphis | |
Memphis, Tennessee, United States, 38103 | |
United States, Virginia | |
Med College of Virginia | |
Richmond, Virginia, United States, 23219 | |
United States, Washington | |
Children's Hospital & Medical Center / Seattle ACTU | |
Seattle, Washington, United States, 981050371 |
Study Chair: | Gwendolyn Scott | Univ of Miami (Pediatric) |
Study Chair: | Mary Jo O'Sullivan | Univ of Miami (Pediatric) |
Study ID Numbers: | ACTG 354, PACTG 354 |
Study First Received: | November 2, 1999 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00000888 |
Health Authority: | United States: Federal Government |
Pregnancy Pregnancy Complications, Infectious Drug Therapy, Combination Administration, Oral Zidovudine |
HIV Protease Inhibitors Ritonavir Disease Transmission, Vertical Anti-HIV Agents Fetal Blood |
Virus Diseases Sexually Transmitted Diseases, Viral Pregnancy Complications Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Pregnancy Complications, Infectious Lamivudine Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |