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

Completed · Phase 1

Conditions studied: HIV Infections, Pregnancy

In brief

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.

Key facts

Study ID

NCT00000878

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

26

Expected to finish

2001-10-01

Last updated by the study team

2021-10-29

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• UCLA Med Ctr / Pediatric — Los Angeles, California, United States
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami / Jackson Memorial Hosp — Miami, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Univ of Chicago Children's Hosp — Chicago, Illinois, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Brigham and Women's Hosp — Boston, Massachusetts, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• Children's Hosp at Albany Med Ctr — Albany, New York, United States
• SUNY Health Sciences Ctr at Syracuse / Pediatrics — Syracuse, New York, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Temple Univ School of Medicine — Philadelphia, Pennsylvania, United States
• Regional Med Ctr at Memphis — Memphis, Tennessee, United States
• Saint Jude Children's Research Hosp of Memphis — Memphis, Tennessee, United States
• Children's Hospital & Medical Center / Seattle ACTU — Seattle, Washington, United States
• Univ of Puerto Rico / Univ Children's Hosp AIDS — San Juan, Puerto Rico
• San Juan City Hosp — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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