NCT00000952

Brief Summary

The study examines the safety and effectiveness of ritonavir (an anti-HIV drug), alone and in combination with other anti-HIV drugs, in HIV-positive children under 2 years of age. This study will also determine the most effective doses of ritonavir for future pediatric HIV studies. Infants infected with HIV by their mothers experience faster disease progression than adults or older children. Treatment with anti-HIV drugs administered at an early age may slow disease progression in infant populations.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Dose-Response Relationship, DrugDrug Therapy, CombinationZidovudineHIV Protease InhibitorsRitonavirLamivudineAnti-HIV Agents

Interventions

RitonavirDRUG
LamivudineDRUG
ZidovudineDRUG

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children may be eligible for this study if they:
  • Are HIV-positive. (Infants under 3 months old presumed to be HIV-positive are eligible to participate in the single-dose phase of the study.)
  • Are between the ages of 4 weeks and 2 years (consent of parent or guardian required).

You may not qualify if:

  • Children will not be eligible for this study if they:
  • Have an opportunistic (AIDS-related) infection within 2 months of study entry.
  • Are allergic to 3TC and/or ZDV.
  • Have received anti-HIV drugs for 6 to 12 weeks.
  • Have any infections requiring treatment.
  • Are experiencing wasting (significant weight loss).
  • Have any malignancies (cancer).
  • Have certain immune diseases, are being fed through a tube, or have HIV-related encephalopathy (a degenerative disease of the brain).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, 90806, United States

Location

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, 92103, United States

Location

Howard Univ. Washington DC NICHD CRS

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

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, 02115, United States

Location

NYU Med. Ctr., Dept. of Medicine

New York, New York, 10016, United States

Location

Nyu Ny Nichd Crs

New York, New York, 10016, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

Incarnation Children's Ctr.

New York, New York, 10032, United States

Location

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, 10037, United States

Location

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, 19104, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 38105, United States

Location

Related Publications (3)

  • Scott ZA, Chadwick EG, Catalina MD, McManus M, Yogev R, Palumbo P, Britto P, Sullivan JL, Luzuriaga K. HIV-1-specific CD8+T cells in vertically infected infants: early responses and the effects of antiretroviral therapy. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 169)

    BACKGROUND

  • Zhao Y, Vetterick T, Lewis D, Yu M, Chadwick E, Yogev R, Coberly SK, Palumbo P. Genotypic mutations in the protease (Pr) and reverse transcriptase (RT) genes associated with antiretroviral resistance to combination therapy with ritonavir/AZT/3TC: a virological sub-study of PACTG 345. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 467)

    BACKGROUND

  • 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: 16148846RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

RitonavirLamivudineZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Officials

  • Ram Yogev

    STUDY CHAIR

  • Ellen Chadwick

    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

January 1, 2004

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

US(12)