Completed
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
26
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
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).
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 20 locations
1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
2
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Status Unknown
3
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
Status Unknown
4
Howard Univ Hosp
Washington D.C., District of Columbia, United States, 20060
Status Unknown
5
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States, 32209
Status Unknown
6
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States, 33136
Status Unknown
7
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
8
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
Status Unknown
9
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Status Unknown
10
Brigham and Women's Hosp
Boston, Massachusetts, United States, 02115
Status Unknown
11
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
12
Children's Hosp at Albany Med Ctr
Albany, New York, United States, 12208
Status Unknown
13
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States, 13210
Status Unknown
14
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
Status Unknown
15
Temple Univ School of Medicine
Philadelphia, Pennsylvania, United States, 191341095
Status Unknown
16
Regional Med Ctr at Memphis
Memphis, Tennessee, United States, 38103
Status Unknown
17
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States, 381052794
Status Unknown
18
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Status Unknown
19
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Status Unknown
20
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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