NCT00117728

Brief Summary

This study is designed to test if a sequential protease-inhibitor (PI) - / nevirapine (NVP) -based regimen is effective for the treatment of HIV-infected children when previous NVP exposure has occurred as part of programs to prevent mother-to-child transmission (pMTCT).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2005

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 29, 2007

Status Verified

January 1, 2006

First QC Date

July 6, 2005

Last Update Submit

June 28, 2007

Conditions

AIDSHIV Infections

Keywords

Non-nucleoside reverse transcriptase inhibitorDrug ResistanceHIV SeronegativityTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Virologic suppression at 6 months after randomization

Secondary Outcomes (4)

  • To compare the time to virologic failure up to 18 months post randomization

  • to examine the associations between detection of drug resistance mutation and virologic response to treatment

  • to compare the toxicity profiles and adherence in the two groups

  • to describe the emergence of genotypic resistance in the two groups

Interventions

nevirapineDRUG

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • NVP-exposure as part of pMTCT-prophylaxis around delivery
  • HIV-positive
  • Eligible for treatment
  • Plans to stay in the area for the next 6 months

You may not qualify if:

  • Already on anti-retroviral treatment
  • History of toxicity to perinatal NVP
  • Grade 3 or greater elevation of liver function tests
  • Being treated for a severe acute opportunistic infection or tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coronation Hospital

Johannesburg, South Africa

RECRUITING

Related Publications (4)

  • Strehlau R, Kuhn L, Abrams EJ, Coovadia A. HIV-associated neurodevelopmental delay: prevalence, predictors and persistence in relation to antiretroviral therapy initiation and viral suppression. Child Care Health Dev. 2016 Nov;42(6):881-889. doi: 10.1111/cch.12399. Epub 2016 Aug 22.

    PMID: 27546069DERIVED

  • Shiau S, Kuhn L, Strehlau R, Martens L, McIlleron H, Meredith S, Wiesner L, Coovadia A, Abrams EJ, Arpadi SM. Sex differences in responses to antiretroviral treatment in South African HIV-infected children on ritonavir-boosted lopinavir- and nevirapine-based treatment. BMC Pediatr. 2014 Feb 12;14:39. doi: 10.1186/1471-2431-14-39.

    PMID: 24521425DERIVED

  • Kuhn L, Coovadia A, Strehlau R, Martens L, Hu CC, Meyers T, Sherman G, Hunt G, Persaud D, Morris L, Tsai WY, Abrams EJ. Switching children previously exposed to nevirapine to nevirapine-based treatment after initial suppression with a protease-inhibitor-based regimen: long-term follow-up of a randomised, open-label trial. Lancet Infect Dis. 2012 Jul;12(7):521-30. doi: 10.1016/S1473-3099(12)70051-8. Epub 2012 Mar 16.

    PMID: 22424722DERIVED

  • Coovadia A, Abrams EJ, Stehlau R, Meyers T, Martens L, Sherman G, Hunt G, Hu CC, Tsai WY, Morris L, Kuhn L. Reuse of nevirapine in exposed HIV-infected children after protease inhibitor-based viral suppression: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1082-90. doi: 10.1001/jama.2010.1278.

    PMID: 20823434DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Louise Kuhn, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 8, 2005

Study Start

April 1, 2005

Study Completion

September 1, 2010

Last Updated

June 29, 2007

Record last verified: 2006-01

Locations

ZA(1)