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COMPLETED Phase 2

Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women

NCT00604175 · View on ClinicalTrials.gov ↗

Study Summary

Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV infection can cause genital warts and certain cervical problems, including cervical cancer. HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of this study was to determine whether the quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in HIV-infected women.

Interventions

  • BIOLOGICAL Quadrivalent HPV vaccine

Study Locations (20)

California

  • Usc La Nichd Crs — Alhambra
  • University of California, UC San Diego CRS — La Jolla
  • Miller Children's Hosp. Long Beach CA NICHD CRS — Long Beach
  • University of Southern California CRS — Los Angeles
  • UCLA CARE Center CRS — Los Angeles
  • Stanford AIDS Clinical Trials Unit CRS — Palo Alto
  • UCSD Antiviral Research Center CRS — San Diego
  • Ucsf Hiv/Aids Crs — San Francisco

Florida

  • South Florida CDTC Ft Lauderdale NICHD CRS — Fort Lauderdale
  • Univ. of Florida Jacksonville NICHD CRS — Jacksonville
  • Pediatric Perinatal HIV Clinical Trials Unit CRS — Miami
  • The University of Miami AIDS Clinical Research Unit (ACRU) CRS — Miami

Colorado

  • University of Colorado Hospital CRS — Aurora
  • Denver Public Health CRS — Denver

District of Columbia

  • Georgetown University CRS (GU CRS) — Washington D.C.
  • Howard Univ. Washington DC NICHD CRS — Washington D.C.

Illinois

  • Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program — Chicago
  • Northwestern University CRS — Chicago

Alabama

  • Alabama Therapeutics CRS — Birmingham

Georgia

  • The Ponce de Leon Center CRS — Atlanta

Trial Details

FieldValue
Enrollment Target 319 participants
Start Date 2008-02
Est. Completion 2012-11
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00604175

The ClinicalTrials.gov registry entry for NCT00604175 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 319 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention — of which Quadrivalent HPV vaccine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00604175 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00604175 about?

NCT00604175 is a clinical study titled "Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women". Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV infection can cause genital warts and certain cervical problems, including cervical cancer. HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of this study was to deter...

What is the current status of trial NCT00604175?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 319 participants. The study started on 2008-02. Estimated completion is 2012-11.

What conditions does trial NCT00604175 study?

This clinical trial studies the following conditions: HIV Infections, Sexually Transmitted Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00604175?

The interventions under investigation include: Quadrivalent HPV vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00604175?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00604175 being conducted?

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

Related

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