Completed
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
24
Participants Needed
4
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 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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
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: 4 locations
1
UCSF Pediatric AIDS CRS
San Francisco, California, United States, 94143
Status Unknown
2
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
Status Unknown
3
Jacobi Med. Ctr.
The Bronx, New York, United States, 10461
Status Unknown
4
Montefiore Med. Ctr. - AECOM
The Bronx, New York, United States
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
PREVENTION
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here