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Ensayos clínicos

Ensayos clínicos

A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00000878, ACTG 332
  • Concluido

Propósito del estudio

The purpose of this study is to evaluate the safety and tolerance of 2 anti-HIV drugs, d4T and 3TC, given in combination to HIV-positive pregnant women and their infants. Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine (ZDV) to treat HIV and reduce the chances of giving HIV to their babies. It recently has been shown that a combination of drugs may be more effective than ZDV alone. This study tests the effectiveness of combinations of ZDV, d4T, and 3TC.

Afección:Fase:
Infecciones por el VIH
Embarazo
Fase 1

Detalles del estudio

New antiretroviral agents or combinations are sought that are as efficacious as ZDV and that would be effective in reducing the rate of vertical transmission of HIV in women who have been long-term recipients of ZDV. d4T is a good candidate drug. It is a thymidine nucleoside analogue that inhibits replication of HIV at concentrations similar to those of ZDV which have anti-HIV activity. The demonstrated safety profile of d4T, the ease of administration, and, most importantly, preliminary efficacy data, especially in combination with 3TC, make this an excellent candidate combination for a Phase I perinatal trial.

Two cohorts of women and infants are enrolled in this study. The first five mother/infant pairs enrolled comprise Group I. Mothers enrolled in this group must allow their infants to receive ZDV. Eight mother/infant pairs are then enrolled in Group II; Group II infants are allocated into two groups: those whose mothers allow the administration of ZDV (Group IIA) and those whose mothers do not (Group IIB). Group I: Women: Beginning at a minimum of 14 weeks gestation: 1. Oral d4T until the start of active labor. 2. Oral 3TC. At the start of active labor (defined as regular uterine contractions resulting in cervical dilation [3-4 cm] and effacement [50-60%]) and during delivery: 1. d4T administered IV as a loading dose followed by a continuous infusion until the umbilical cord is clamped. 2. Oral 3TC if patient's previous dose of 3TC was administered at least 0.5h prior to onset of labor and additional dose of 3TC is administered and the time until next dose is scheduled accordingly. Infants: 1. d4T as a single oral dose on Day 6 (+/- 2 days) and on Day 42 (this dose can be given between Days 35 and 42, inclusive). 2. Oral ZDV (or IV if unable to take oral dosing) for 6 weeks, beginning a maximum of 12 hours after birth. 3. 3TC for 6 weeks, beginning a maximum of 12 hours after birth. Group II: Women: Beginning at a minimum of 14 weeks gestation: 1. Oral d4T until the umbilical cord is clamped. 2. Oral 3TC. At the start of active labor and through delivery: Oral d4T and 3TC as above. If the last doses of d4T and 3TC were given at least 0.5 hours prior to onset of active labor, an additional dose of d4T and 3TC is given and repeated every 12 hours. Infant Group IIA: 1. d4T as a single oral dose on Day 6 (+/- 2 days) and on Day 42 (this dose can be given between Days 35 and 42, inclusive). 2. Oral ZDV (or IV if unable to tolerate oral dosing) for 6 weeks, beginning a maximum of 12 hours after birth. 3. 3TC for 6 weeks, beginning a maximum of 12 hours after birth. Infant Group IIB: Beginning a maximum of 12 hours after birth: 1. d4T for 6 weeks. 2. 3TC for 6 weeks. [AS PER AMENDMENT 9/15/97: If tolerated, infants continue on protocol treatment to 6 weeks of age. At 6 weeks, infants should receive standard care, including PCP prophylaxis, from an HIV specialist/pediatrician. HIV-infected infants are offered ACTG trial enrollment or open-label treatment based on best clinical judgment of their physician.] [AS PER AMENDMENT 2/19/99: Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study.]New antiretroviral agents or combinations are sought that are as efficacious as ZDV and that would be effective in reducing the rate of vertical transmission of HIV in women who have been long-term recipients of ZDV. d4T is a good candidate drug. It is a thymidine nucleoside analogue that inhibits replication of HIV at concentrations similar to those of ZDV which have anti-HIV activity. The demonstrated safety profile of d4T, the ease of administration, and, most importantly, preliminary efficacy data, especially in combination with 3TC, make this an excellent candidate combination for a Phase I perinatal trial.

Two cohorts of women and infants are enrolled in this study. The first five mother/infant pairs enrolled comprise Group I. Mothers enrolled in this group must allow their infants to receive ZDV. Eight mother/infant pairs are then enrolled in Group II; Group II infants are allocated into two groups: those whose mothers allow the administration of ZDV (Group IIA) and those whose mothers do not (Group IIB). Group I: Women: Beginning at a minimum of 14 weeks gestation: 1. Oral d4T until the start of active labor. 2. Oral 3TC. At the start of active labor (defined as regular uterine contractions resulting in cervical dilation [3-4 cm] and effacement [50-60%]) and during delivery: 1. d4T administered IV as a loading dose followed by a continuous infusion until the umbilical cord is clamped. 2. Oral 3TC if patient's previous dose of 3TC was administered at least 0.5h prior to onset of labor and additional dose of 3TC is administered and the time until next dose is scheduled accordingly. Infants: 1. d4T as a single oral dose on Day 6 (+/- 2 days) and on Day 42 (this dose can be given between Days 35 and 42, inclusive). 2. Oral ZDV (or IV if unable to take oral dosing) for 6 weeks, beginning a maximum of 12 hours after birth. 3. 3TC for 6 weeks, beginning a maximum of 12 hours after birth. Group II: Women: Beginning at a minimum of 14 weeks gestation: 1. Oral d4T until the umbilical cord is clamped. 2. Oral 3TC. At the start of active labor and through delivery: Oral d4T and 3TC as above. If the last doses of d4T and 3TC were given at least 0.5 hours prior to onset of active labor, an additional dose of d4T and 3TC is given and repeated every 12 hours. Infant Group IIA: 1. d4T as a single oral dose on Day 6 (+/- 2 days) and on Day 42 (this dose can be given between Days 35 and 42, inclusive). 2. Oral ZDV (or IV if unable to tolerate oral dosing) for 6 weeks, beginning a maximum of 12 hours after birth. 3. 3TC for 6 weeks, beginning a maximum of 12 hours after birth. Infant Group IIB: Beginning a maximum of 12 hours after birth: 1. d4T for 6 weeks. 2. 3TC for 6 weeks. [AS PER AMENDMENT 9/15/97: If tolerated, infants continue on protocol treatment to 6 weeks of age. At 6 weeks, infants should receive standard care, including PCP prophylaxis, from an HIV specialist/pediatrician. HIV-infected infants are offered ACTG trial enrollment or open-label treatment based on best clinical judgment of their physician.] [AS PER AMENDMENT 2/19/99: Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study.]

Criterios de inclusión

    Women may be eligible for this study if they: Are HIV-positive. Are at least 13 years old (need consent of parent or guardian if under 18). Are unable to or refuse to take ZDV or the woman's doctor says that she should take d4T. Are 14 to 34 weeks pregnant.

Criterios de exclusión

    Women will not be eligible for this study if they: Have a history of peripheral neuropathy. Have an active opportunistic infection and/or serious bacterial infection within 14 days of study entry. Have severe diarrhea. Are allergic to d4T or 3TC. Use illicit drugs or abuse alcohol. Are taking anti-HIV drugs other than study medications. Are planning to breast-feed. Are having a problem pregnancy (baby is not developing correctly or will not survive birth) or have had pregnancy complications in the past. Babies will not be eligible for this study if they: Are unable to take medications by mouth for more than 72 hours. Have severe birth defects or other life-threatening conditions. Are underweight (less than 2 kg).

Centros de estudio/contactos

California

    Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California, 905022004, United States

    UCLA Med Ctr / Pediatric, Los Angeles, California, 900951752, United States

    Los Angeles County - USC Med Ctr, Los Angeles, California, 90033, United States

District of Columbia

    Howard Univ Hosp, Washington, District of Columbia, 20060, United States

Florida

    Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida, 32209, United States

    Univ of Miami / Jackson Memorial Hosp, Miami, Florida, 33136, United States

    Univ of Miami (Pediatric), Miami, Florida, 33161, United States

Illinois

    Univ of Chicago Children's Hosp, Chicago, Illinois, 606371470, United States

Massachusetts

    Brigham and Women's Hosp, Boston, Massachusetts, 02115, United States

    Children's Hosp of Boston, Boston, Massachusetts, 021155724, United States

New Jersey

    Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey, 071032714, United States

New York

    Children's Hosp at Albany Med Ctr, Albany, New York, 12208, United States

    SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York, 13210, United States

North Carolina

    Duke Univ Med Ctr, Durham, North Carolina, 277103499, United States

Pennsylvania

    Temple Univ School of Medicine, Philadelphia, Pennsylvania, 191341095, United States

Tennessee

    Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee, 381052794, United States

    Regional Med Ctr at Memphis, Memphis, Tennessee, 38103, United States

Washington

    Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington, 981050371, United States

    San Juan City Hosp, San Juan, Washington, 009367344, Puerto Rico

    Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan, Washington, 009365067, Puerto Rico

Actualizado: 13 de octubre del 2004

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