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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: | NCT00000920 |
The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant women and to see if it is safe to give 3TC and ZDV to their newborns. Another purpose is to see what levels of SQV, low-dose RTV, ZDV, and 3TC are found in mothers and what levels of ZDV and 3TC are seen in newborns. Another purpose of this study is to see whether SQV passes from mother to newborn and if it passes at a level that is safe for the newborn.
Although ZDV has been able to reduce the rate of transmission of HIV from mother to child, it may be possible to reduce it further by using a combination of anti-HIV drugs. This study adds SQV (a protease inhibitor [PI]) with RTV (another PI) and 3TC (a reverse transcriptase inhibitor) to the mother's ZDV regimen.
Condition | Intervention | Phase |
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HIV Infections Pregnancy |
Drug: Ritonavir Drug: Saquinavir Drug: Lamivudine Drug: Zidovudine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Pharmacokinetics Study |
Official Title: | A Phase I Trial of the Safety and Pharmacokinetics of Fortovase (Saquinavir-SGC) Co-Administered With Low Dose (Ritonavir) RTV, ZDV and 3TC in HIV Seropositive Pregnant Women During Gestation and Postpartum, and in Their Infant's Post-Maternal Dosing |
Estimated Enrollment: | 24 |
Study Start Date: | September 1997 |
Although administration of ZDV to mother-infant pairs has dramatically reduced perinatal HIV infection, the goal is to reduce it further to less than 2%. In order to achieve this, combination strategies need to be developed for 2 purposes: 1) to reduce the perinatal transmission rate to goal levels; and 2) to provide other combination therapies for HIV-infected mothers whose virus has become resistant to ZDV, who have a very high viral load, or who have previously transmitted HIV while on ZDV. This study adds 3TC (another reverse transcriptase inhibitor) and SQV (a protease inhibitor [PI]) [AS PER AMENDMENT 08/15/00: with low-dose RTV (another PI)] to the mother's ZDV regimen.
During the antepartum period, mothers receive SQV with [AS PER AMENDMENT 08/15/00: low-dose RTV plus] ZDV and 3TC. At onset of active labor, mothers receive loading doses of each of the study drugs, then receive study drugs for 12 weeks postpartum on the same schedule as during the antenatal period. Within 12 hours of delivery, infants begin receiving 3TC and ZDV and continue until 6 weeks of age. Mothers are followed until 12 weeks postpartum and babies are followed until 6 months of age. [AS PER AMENDMENT 02/09/99: For maternal dosing, 1 Combivir tablet (containing 3TC and ZDV) may be administered in place of the individual agents 3TC and ZDV. Patients who prematurely discontinue study treatment should continue to be followed for the duration of the study.]
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients may not be eligible for this study if they:
United States, California | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
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, Illinois | |
Univ of Illinois College of Medicine / Pediatrics | |
Chicago, Illinois, United States, 60612 | |
United States, Louisiana | |
Tulane Univ / Charity Hosp of New Orleans | |
New Orleans, Louisiana, United States, 701122699 | |
Univ Hosp | |
New Orleans, Louisiana, United States, 70112 | |
United States, Michigan | |
Children's Hosp of Michigan | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
Newark, New Jersey, United States, 071032714 | |
United States, New York | |
Columbia Presbyterian Med Ctr | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 277103499 | |
United States, South Carolina | |
Med Univ of South Carolina | |
Charleston, South Carolina, United States, 294253312 | |
United States, Washington | |
Children's Hospital & Medical Center / Seattle ACTU | |
Seattle, Washington, United States, 981050371 | |
Puerto Rico | |
Univ of Puerto Rico / Univ Children's Hosp AIDS | |
San Juan, Puerto Rico, 009365067 |
Study Chair: | Carmen Zorrilla | |
Study Chair: | Arlene Bardeguez | |
Study Chair: | Jane Pitt | |
Study Chair: | Russell Van Dyke |
Study ID Numbers: | ACTG 386, PACTG 386 |
Study First Received: | November 2, 1999 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00000920 |
Health Authority: | United States: Food and Drug Administration |
Pregnancy Drug Therapy, Combination Zidovudine Pregnancy Complications |
Ritonavir Lamivudine Saquinavir Anti-HIV Agents |
Sexually Transmitted Diseases, Viral Pregnancy Complications Saquinavir Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Immunologic Deficiency Syndromes |
Virus Diseases HIV Seropositivity HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
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 |