A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

NCT00000878 | Completed Phase 1

• 3 other identifiers: ACTG 33211304PACTG 332
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 20

Brief Summary

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

HIV Infections; Pregnancy

Keywords

Pregnancy; Pregnancy Complications, Infectious; Drug Therapy, Combination; Stavudine; Lamivudine; Disease Transmission, Vertical; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load

Interventions

Lamivudine DRUG

Stavudine DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (20)

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

UCLA Med Ctr / Pediatric

Los Angeles, California, 900951752, United States

Location

Harbor - UCLA Med Ctr / UCLA School of Medicine

Los Angeles, California, 905022004, United States

Location

Howard Univ Hosp

Washington D.C., District of Columbia, 20060, United States

Location

Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, 32209, United States

Location

Univ of Miami / Jackson Memorial Hosp

Miami, Florida, 33136, United States

Location

Univ of Miami (Pediatric)

Miami, Florida, 33161, United States

Location

Univ of Chicago Children's Hosp

Chicago, Illinois, 606371470, United States

Location

Children's Hosp of Boston

Boston, Massachusetts, 021155724, United States

Location

Brigham and Women's Hosp

Boston, Massachusetts, 02115, United States

Location

Univ of Medicine & Dentistry of New Jersey / Univ Hosp

Newark, New Jersey, 071032714, United States

Location

Children's Hosp at Albany Med Ctr

Albany, New York, 12208, United States

Location

SUNY Health Sciences Ctr at Syracuse / Pediatrics

Syracuse, New York, 13210, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 277103499, United States

Location

Temple Univ School of Medicine

Philadelphia, Pennsylvania, 191341095, United States

Location

Regional Med Ctr at Memphis

Memphis, Tennessee, 38103, United States

Location

Saint Jude Children's Research Hosp of Memphis

Memphis, Tennessee, 381052794, United States

Location

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, 981050371, United States

Location

Univ of Puerto Rico / Univ Children's Hosp AIDS

San Juan, 009365067, Puerto Rico

Location

San Juan City Hosp

San Juan, 009367344, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious

Interventions

Lamivudine; Stavudine; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

Study Officials

• Nancy Wade

  STUDY CHAIR

• Sandra Burchett

  STUDY CHAIR

• Salih Yasin

  STUDY CHAIR

• Jash Unadkat

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 2001
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

PR (2); US (18)