A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Pregnancy
Intervention: Lamivudine (Drug); Stavudine (Drug); Zidovudine (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Nancy Wade, Study Chair
Sandra Burchett, Study Chair
Salih Yasin, Study Chair
Jash Unadkat, Study Chair
Summary
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.
Clinical Details
Official title: A Phase I/II, Open-Label Study to Evaluate the Safety, Tolerance and Pharmacokinetics of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Infected Pregnant Women and Their Infants
Study design: Treatment, Pharmacokinetics Study
Detailed description:
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.]
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
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).
Locations and Contacts
San Juan City Hosp, San Juan 009367344, Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan 009365067, Puerto Rico
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
Howard Univ Hosp, Washington, District of Columbia 20060, United States
Univ of Miami (Pediatric), Miami, Florida 33161, United States
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 Chicago Children's Hosp, Chicago, Illinois 606371470, United States
Children's Hosp of Boston, Boston, Massachusetts 021155724, United States
Brigham and Women's Hosp, Boston, Massachusetts 02115, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey 071032714, United States
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
Duke Univ Med Ctr, Durham, North Carolina 277103499, United States
Temple Univ School of Medicine, Philadelphia, Pennsylvania 191341095, United States
Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee 381052794, United States
Regional Med Ctr at Memphis, Memphis, Tennessee 38103, United States
Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington 981050371, United States
Additional Information
Click here for more information about Zidovudine Click here for more information about Stavudine Click here for more information about Lamivudine Haga clic aquí para ver información sobre este ensayo clínico en español.
Last updated: May 12, 2006
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