Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies

NCT00000888 | Completed Phase 1

• 3 other identifiers: ACTG 35410604PACTG 354
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to see if it is safe and effective to give ritonavir (RTV) plus lamivudine (3TC) plus zidovudine (ZDV) to HIV-infected pregnant women during pregnancy and to their babies after birth. Pregnant women who are HIV-positive are at risk of giving HIV to their babies during pregnancy or delivery. It is important to learn how to prevent HIV-positive pregnant women from giving HIV to their babies. RTV and ZDV have been shown to be safe and effective against HIV in adults. The combination of 3 anti-HIV drugs (RTV, 3TC, and ZDV) may help prevent HIV infection from mother to infant but studies are needed to determine whether they are safe and effective during pregnancy.

Conditions

HIV Infections; Pregnancy

Keywords

Pregnancy; Pregnancy Complications, Infectious; Drug Therapy, Combination; Administration, Oral; Zidovudine; HIV Protease Inhibitors; Ritonavir; Disease Transmission, Vertical; Anti-HIV Agents; Fetal Blood

Interventions

Ritonavir DRUG

Lamivudine DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• 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 between 14 and 32 weeks pregnant.
• Are at least 13 years old (consent of parent or guardian required if under 18).
• Have the consent of the baby's father (if he can be reached).

You may not qualify if:

• Women will not be eligible for this study if they:
• Are having problems with their pregnancy.
• Have a history of problem pregnancies including miscarriages, birth defects, stillbirths, or giving birth to premature or low-birth-weight babies.
• Have had side effects to ZDV, 3TC, or RTV.
• Have an active opportunistic (AIDS-related) or other serious infection.
• Have other serious conditions such as heart or lung problems, blood disorders, diabetes, or seizures.
• Are pregnant with more than one baby (such as twins or triplets).
• Are taking other experimental medications.
• Are taking other anti-HIV medications.
• Are taking certain other medications including those for cancer, blood pressure, or seizures.
• Are abusing drugs or alcohol.
• Are breast-feeding.

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 (5)

Univ. of Miami Miller School of Medicine - Jackson Memorial Hosp.

Miami, Florida, 33136, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33161, United States

Location

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, 48201, United States

Location

Regional Med Ctr at Memphis

Memphis, Tennessee, 38103, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• Chadwick EG, Rodman JH, Britto P, Powell C, Palumbo P, Luzuriaga K, Hughes M, Abrams EJ, Flynn PM, Borkowsky W, Yogev R; PACTG Protocol 345 Team. Ritonavir-based highly active antiretroviral therapy in human immunodeficiency virus type 1-infected infants younger than 24 months of age. Pediatr Infect Dis J. 2005 Sep;24(9):793-800. doi: 10.1097/01.inf.0000177281.93658.df.

  PMID: 16148846 RESULT

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious

Interventions

Ritonavir; Lamivudine; 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)

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

Study Officials

• Gwendolyn Scott

  Univ of Miami (Pediatric)

  STUDY CHAIR

• Mary Jo O'Sullivan

  Univ of Miami (Pediatric)

  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: April 1, 2001
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (5)