A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
This study has been completed.
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000878
First received: November 2, 1999
Last updated: May 17, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Pregnancy |
Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Show Detailed Description
Eligibility| Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000878
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000878
Locations
| United States, California | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| UCLA Med Ctr / Pediatric | |
| Los Angeles, California, United States, 900951752 | |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | |
| Los Angeles, California, United States, 905022004 | |
| United States, District of Columbia | |
| Howard Univ Hosp | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| Univ of Florida Health Science Ctr / Pediatrics | |
| Jacksonville, Florida, United States, 32209 | |
| Univ of Miami / Jackson Memorial Hosp | |
| Miami, Florida, United States, 33136 | |
| Univ of Miami (Pediatric) | |
| Miami, Florida, United States, 33161 | |
| United States, Illinois | |
| Univ of Chicago Children's Hosp | |
| Chicago, Illinois, United States, 606371470 | |
| United States, Massachusetts | |
| Children's Hosp of Boston | |
| Boston, Massachusetts, United States, 021155724 | |
| Brigham and Women's Hosp | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New Jersey | |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
| Newark, New Jersey, United States, 071032714 | |
| United States, New York | |
| Children's Hosp at Albany Med Ctr | |
| Albany, New York, United States, 12208 | |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 277103499 | |
| United States, Pennsylvania | |
| Temple Univ School of Medicine | |
| Philadelphia, Pennsylvania, United States, 191341095 | |
| United States, Tennessee | |
| Regional Med Ctr at Memphis | |
| Memphis, Tennessee, United States, 38103 | |
| Saint Jude Children's Research Hosp of Memphis | |
| Memphis, Tennessee, United States, 381052794 | |
| United States, Washington | |
| Children's Hospital & Medical Center / Seattle ACTU | |
| Seattle, Washington, United States, 981050371 | |
| Puerto Rico | |
| Univ of Puerto Rico / Univ Children's Hosp AIDS | |
| San Juan, Puerto Rico, 009365067 | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Study Chair: | Nancy Wade | |
| Study Chair: | Sandra Burchett | |
| Study Chair: | Salih Yasin | |
| Study Chair: | Jash Unadkat |
More Information
Additional Information:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000878 History of Changes |
| Other Study ID Numbers: | ACTG 332 11304 PACTG 332 |
| Study First Received: | November 2, 1999 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Pregnancy Pregnancy Complications, Infectious Drug Therapy, Combination Stavudine Lamivudine |
Disease Transmission, Vertical Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine Stavudine |
Lamivudine Reverse Transcriptase Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on September 30, 2016