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NCT00339040 · ClinicalTrials.gov registry record · Phase 2

Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children

A Phase 2 study of HIV Infections and Sexually Transmitted Diseases, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
130
Enrollment target
20
Study locations

NCT00339040 is a Phase 2 study of HIV Infections and Sexually Transmitted Diseases that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 130 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT00339040, a Phase 2 study of HIV Infections and Sexually Transmitted Diseases, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
130 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between the ages of 7 and 12 years.

Interventions

  • BIOLOGICAL Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV)
  • OTHER Placebo/QHPV

Study Locations (20)

California

  • Usc La Nichd Crs - Alhambra
  • Miller Children's Hosp. Long Beach CA NICHD CRS - Long Beach
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS - Los Angeles
  • Children's Hosp. of Orange County - Orange
  • UCSD Mother-Child-Adolescent Program CRS - San Diego
  • Univ. of California San Francisco NICHD CRS - San Francisco

Florida

  • South Florida CDTC Ft Lauderdale NICHD CRS - Fort Lauderdale
  • Univ. of Florida Jacksonville NICHD CRS - Jacksonville
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS - Miami

Illinois

  • Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program - Chicago
  • Rush Univ. Cook County Hosp. Chicago NICHD CRS - Chicago
  • Chicago Children's CRS - Chicago

Massachusetts

  • Children's Hosp. of Boston NICHD CRS - Boston
  • Boston Medical Center Ped. HIV Program NICHD CRS - Boston
  • WNE Maternal Pediatric Adolescent AIDS CRS - Worcester

District of Columbia

  • Children's National Med. Ctr. Washington DC NICHD CRS - Washington D.C.
  • Howard Univ. Washington DC NICHD CRS - Washington D.C.

Colorado

  • Univ. of Colorado Denver NICHD CRS - Aurora

Connecticut

  • Connecticut Children's Med. Ctr. - Hartford

Louisiana

  • Children's Hosp. - New Orleans

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2006-10
Est. Completion 2009-08
Phase Phase 2

What the Registry Record Tells You About NCT00339040

The ClinicalTrials.gov registry entry for NCT00339040 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (71% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV) is the first listed.

NCT00339040 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT00339040 about?

NCT00339040 is a clinical study titled "Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children". The purpose of this study is to determine the safety of and immune response to a new human papillomavirus (HPV) vaccine in HIV (Human immunodeficiency virus) infected children between the ages of 7 and 12 years.

What is the current status of trial NCT00339040?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2006-10. Estimated completion is 2009-08.

What conditions does trial NCT00339040 study?

This clinical trial studies the following conditions: HIV Infections, Sexually Transmitted Diseases.

What interventions are being tested in trial NCT00339040?

The interventions under investigation include: Quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle (VLP) or Quadrivalent human papillomavirus vaccine (QHPV) (BIOLOGICAL), Placebo/QHPV (OTHER).

Who is sponsoring clinical trial NCT00339040?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00339040 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.