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Ensayos clínicos

Ensayos clínicos

A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000944, ACTG 358
  • Concluido

Propósito del estudio

To assess the pharmacokinetics, safety, tolerance, and efficacy of indinavir when given in combination with lamivudine (3TC) and zidovudine (ZDV) to HIV-1-infected pregnant women. To assess the pharmacokinetics of indinavir in cord and neonatal samples following maternal dosing and the safety and tolerance of prior maternal dosing in the newborn. To assess the antiviral effect and durability of the combination of indinavir, 3TC, and ZDV in reducing maternal plasma HIV RNA levels.

Afección:Fase:
Infecciones por el VIH
Embarazo
Fase 1

Detalles del estudio

Despite the dramatic reduction of perinatal HIV transmission following the administration of ZDV to mothers and infants, new, more effective strategies are needed. An increasing number of women may require combination antiretroviral therapy for their own disease because they may be resistant to ZDV, may have high viral loads, or may have previously transmitted HIV to an infant while on ZDV monotherapy. The initiation of triple combination therapy, including a protease inhibitor indinavir, during gestation may be the most effective in reducing maternal virus load prior to delivery, thereby potentially benefitting both mother and child.Women: Antepartum (until active labor): Indinavir plus 3TC plus ZDV. Intrapartum (active labor until cord clamping): 3TC plus ZDV. Postpartum (after cord clamped to 12 weeks): Indinavir plus 3TC plus ZDV. Infants: 3TC plus ZDV as soon as oral intake is tolerated (preferably within 12 hours of birth) and continuing for 6 weeks. [AS PER AMENDMENT 1/27/99: For maternal dosing, one Combivir tablet bid can be substituted for the individual formulation of 3TC and ZDV. For mothers who receive Combivir during the antepartum period, Combivir is held during labor and delivery, and the separate formulations of ZDV and 3TC are used. Patiens who prematurely discontinue study treatment should continue to be followed on study for the duration of the study.]

Criterios de exclusión

    Women will not be eligible for this study if they: Cannot take 3TC or ZDV. Have an active opportunistic (HIV-associated) or bacterial infection at study entry. Have chronic diarrhea. Have epilepsy or cancer. Are pregnant with more than 2 children (triplets, etc.) Have risk factors for premature birth, or other problems with their pregnancy. Have any immediate life-threatening illness. Have severe anemia or other illness for which they require blood products. Have a history of chronic liver or kidney disease. Plan to breast-feed.

Centros de estudio/contactos

California

    UCSF Pediatric AIDS CRS, San Francisco, California, 94143, United States

Massachusetts

    HMS - Children's Hosp. Boston, Div. of Infectious Diseases, Boston, Massachusetts, 02115, United States

New York

    Jacobi Med. Ctr., Bronx, New York, 10461, United States

    Montefiore Med. Ctr. - AECOM, Bronx, New York, 10461, United States

Actualizado: 13 de octubre del 2004

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