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

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 is ongoing, but not recruiting participants.

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000878

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 I

MedlinePlus related topics:

AIDS AIDS Medicines AIDS and Pregnancy

Drug Information available for:

Zidovudine Lamivudine Stavudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Pharmacokinetics Study

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

Show Detailed Description

Eligibility

Ages Eligible for Study:	13 Years and older
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000878

Locations


United States, California
	Harbor - UCLA Med Ctr / UCLA School of Medicine
	Los Angeles, California, United States, 905022004
	UCLA Med Ctr / Pediatric
	Los Angeles, California, United States, 900951752
	Los Angeles County - USC Med Ctr
	Los Angeles, California, United States, 90033

United States, District of Columbia
	Howard Univ Hosp
	Washington, District of Columbia, United States, 20060

United States, Florida
	Univ of Miami (Pediatric)
	Miami, Florida, United States, 33161
	Univ of Florida Health Science Ctr / Pediatrics
	Jacksonville, Florida, United States, 32209
	Univ of Miami / Jackson Memorial Hosp
	Miami, Florida, United States, 33136

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
	Saint Jude Children's Research Hosp of Memphis
	Memphis, Tennessee, United States, 381052794
	Regional Med Ctr at Memphis
	Memphis, Tennessee, United States, 38103

United States, Washington
	Children's Hospital & Medical Center / Seattle ACTU
	Seattle, Washington, United States, 981050371

Puerto Rico
	San Juan City Hosp
	San Juan, Puerto Rico, 009367344
	Univ of Puerto Rico / Univ Children's Hosp AIDS
	San Juan, Puerto Rico, 009365067

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

Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site

Click here for more information about Stavudine This link exits the ClinicalTrials.gov site

Click here for more information about Lamivudine This link exits the ClinicalTrials.gov site

Haga clic aquí para ver información sobre este ensayo clínico en español. This link exits the ClinicalTrials.gov site

Study ID Numbers:	ACTG 332, PACTG 332
First Received:	November 2, 1999
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00000878
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

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral

Pregnancy Complications

Stavudine

Pregnancy Complications, Infectious

Acquired Immunodeficiency Syndrome

Zidovudine

Lamivudine

Immunologic Deficiency Syndromes

Virus Diseases

HIV Seropositivity

HIV Infections

Sexually Transmitted Diseases

Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008