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
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: Indinavir sulfate (Drug); Lamivudine (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):
Diana Wara, Study Chair
Yvonne Bryson, Study Chair
Ruth Tuomala, Study Chair
Summary
The purpose of this study is to determine if a combination anti-HIV drug treatment regimen of
indinavir plus lamivudine (3TC) plus zidovudine (ZDV) is effective in treating HIV and in
reducing the chances of passing HIV from mother to child. This study will also examine if
this combination is well tolerated by HIV-positive pregnant women and if a combination of 3TC
plus ZDV is safe for newborns.
Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can
reduce the amount of HIV in the blood. Most HIV-positive pregnant women usually take ZDV to
treat HIV and to reduce the chances of giving HIV to their babies. The combination of drugs
in this study may be more effective than ZDV alone.
Clinical Details
Official title: A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Indinavir Co-Administered With Lamivudine (3TC) and Zidovudine (ZDV) in HIV-1-Infected Pregnant Women During Gestation and Post Partum, and in Their Infants Post Maternal Dosing
Study design: Prevention, Safety Study
Detailed description:
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. 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): Female.
Criteria:
Inclusion Criteria
Women may be eligible for this study if they:
- Are HIV-positive.
- Have been pregnant for 14-28 weeks (are in your 1st or 2nd trimester).
- Have a normal ultrasound exam when they are screened for the study.
- Are able to drink 6 glasses of water a day throughout the study.
- Are at least 13 years old (need consent of parent or guardian if under 18).
Exclusion Criteria
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.
Locations and Contacts
Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan 009365067, Puerto Rico
UCSF / Moffitt Hosp - Pediatric, San Francisco, California 941430105, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California 920930672, United States
San Francisco Gen Hosp, San Francisco, California 94110, United States
Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida 32209, 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
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Columbia Presbyterian Med Ctr, New York, New York 10032, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr, Bronx, New York 10461, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York 13210, United States
Bronx Lebanon Hosp Ctr, Bronx, New York 10457, United States
Texas Children's Hosp / Baylor Univ, Houston, Texas 77030, United States
Additional Information
Click here for more information about Zidovudine Click here for more information about Lamivudine Click here for more information about Indinavir sulfate Haga clic aquí para ver información sobre este ensayo clínico en español.
Last updated: June 23, 2005
|
