A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
Public ClinicalTrials.gov record NCT00000878. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00000878
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 26 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Sep 30, 2001
- Last update posted
- Oct 28, 2021
Ends 2001
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | — |
| UCLA Med Ctr / Pediatric | Los Angeles | California | 900951752 | — |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | Los Angeles | California | 905022004 | — |
| Howard Univ Hosp | Washington D.C. | District of Columbia | 20060 | — |
| Univ of Florida Health Science Ctr / Pediatrics | Jacksonville | Florida | 32209 | — |
| Univ of Miami / Jackson Memorial Hosp | Miami | Florida | 33136 | — |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | — |
| Univ of Chicago Children's Hosp | Chicago | Illinois | 606371470 | — |
| Children's Hosp of Boston | Boston | Massachusetts | 021155724 | — |
| Brigham and Women's Hosp | Boston | Massachusetts | 02115 | — |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark | New Jersey | 071032714 | — |
| Children's Hosp at Albany Med Ctr | Albany | New York | 12208 | — |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | Syracuse | New York | 13210 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 277103499 | — |
| Temple Univ School of Medicine | Philadelphia | Pennsylvania | 191341095 | — |
| Regional Med Ctr at Memphis | Memphis | Tennessee | 38103 | — |
| Saint Jude Children's Research Hosp of Memphis | Memphis | Tennessee | 381052794 | — |
| Children's Hospital & Medical Center / Seattle ACTU | Seattle | Washington | 981050371 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000878, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2021 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00000878 live on ClinicalTrials.gov.