The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata

NCT00941889 | Completed Results

• 1 other identifier: HRPO 07-0648
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.

Conditions

HIV Positive; Anal Condylomata; Anal Warts; HIV Infections

Keywords

HIV; HPV; Anal condylomata; Vaccine; HIV positive patients; Anal condylomata or anal warts

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.

  Persistence of anal warts will be measured by the presence of any lesions at one month follow-up after surgery. Recurrence of anal warts will be measured by the development of new lesions after one month of follow-up.

  Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients who are in the control group received a placebo of saline in the upper extremity at initial visit, 2 months and 6 months after enrollment.

Drug: Saline

Gardasil

ACTIVE COMPARATOR

The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity at initial visit, and again at two months and six months after enrollment.

Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

Interventions

Saline DRUG

0.5 ml

Placebo

Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine DRUG

0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.

Also known as: GARDASIL

Gardasil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age;
• HIV positive status;
• CD4 \> 200 and viral RNA \< 400 on anti-retroviral therapy (HAART) or CD4 \> 350 if not on HARRT;
• the presence of anal warts that require surgical excision/ablation.

You may not qualify if:

• CD4 \< 200 and/or viral RNA \> 400 on HAART or CD4 \< 350 and not on HAART ;
• low burden of anal warts that would not require surgical excision/ablation;
• previous vaccinations against HPV or allergic reactions to any vaccine component;
• patients who are currently pregnant;
• patients with a previous diagnosis of anal cancer;
• patients who are incarcerated;
• patients who have taken immunomodulators (i.e. interferon, interleukin, corticosteroids, etc.) within the last 90 days;
• patients who have had an opportunistic infection in the last 90 days or who have another intercurrent illness that precludes their safe enrollment in this study;
• patients who, in the judgment of the investigators, are unlikely to adhere to the protocol, either because of a substance abuse or psychiatric diagnosis, or other factors that would affect compliance;
• failure to strictly comply with the vaccination schedule.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis, Section of Colon Rectal Surgery

St Louis, Missouri, 63110, United States

Location

Related Publications (13)

• StatBite: Prevalence of HPV in a cohort of U.S. men. J Natl Cancer Inst. 2009 Feb 18;101(4):223. doi: 10.1093/jnci/djp008. Epub 2009 Feb 10. No abstract available.

  PMID: 19211451 BACKGROUND

• Human papillomavirus vaccines. WHO position paper. Wkly Epidemiol Rec. 2009 Apr 10;84(15):118-31. No abstract available. English, French.

  PMID: 19360985 BACKGROUND

• Chitale R. Merck hopes to extend gardasil vaccine to men. J Natl Cancer Inst. 2009 Feb 18;101(4):222-3. doi: 10.1093/jnci/djp014. Epub 2009 Feb 10. No abstract available.

  PMID: 19211446 BACKGROUND

• Gillespie MB, Smith J, Gibbs K, McRackan T, Rubinchik S, Day TA, Sutkowski N. Human papillomavirus and head and neck cancer: a growing concern. J S C Med Assoc. 2008 Dec;104(8):247-51.

  PMID: 19326612 BACKGROUND

• Stanley M. The epidemiology and burden of HPV disease. Nurs Times. 2008 Sep 9-15;104(36):38-40.

  PMID: 18822547 BACKGROUND

• Gross G. Impact of prophylactic human papillomavirus vaccines on dermatology and venereology. G Ital Dermatol Venereol. 2008 Aug;143(4):259-65.

  PMID: 18833082 BACKGROUND

• Herbert J, Coffin J. Reducing patient risk for human papillomavirus infection and cervical cancer. J Am Osteopath Assoc. 2008 Feb;108(2):65-70.

  PMID: 18303060 BACKGROUND

• Dowling TS. Mandating a human papillomavirus vaccine: an investigation into whether such legislation is constitutional and prudent. Am J Law Med. 2008;34(1):65-84. doi: 10.1177/009885880803400103. No abstract available.

  PMID: 18512537 BACKGROUND

• Dunne EF, Markowitz LE. Genital human papillomavirus infection. Clin Infect Dis. 2006 Sep 1;43(5):624-9. doi: 10.1086/505982. Epub 2006 Jul 26.

  PMID: 16886157 BACKGROUND

• Winer RL, Lee SK, Hughes JP, Adam DE, Kiviat NB, Koutsky LA. Genital human papillomavirus infection: incidence and risk factors in a cohort of female university students. Am J Epidemiol. 2003 Feb 1;157(3):218-26. doi: 10.1093/aje/kwf180.

  PMID: 12543621 BACKGROUND

• Vukasin P. Anal condyloma and HIV-associated anal disease. Surg Clin North Am. 2002 Dec;82(6):1199-211, vi. doi: 10.1016/s0039-6109(02)00085-3.

  PMID: 12516848 BACKGROUND

• Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, Wheeler CM, Koutsky LA, Malm C, Lehtinen M, Skjeldestad FE, Olsson SE, Steinwall M, Brown DR, Kurman RJ, Ronnett BM, Stoler MH, Ferenczy A, Harper DM, Tamms GM, Yu J, Lupinacci L, Railkar R, Taddeo FJ, Jansen KU, Esser MT, Sings HL, Saah AJ, Barr E. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005 May;6(5):271-8. doi: 10.1016/S1470-2045(05)70101-7.

  PMID: 15863374 BACKGROUND

• Reisinger KS, Block SL, Lazcano E, et al. A randomized controlled trial to evaluate the safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in preadolescents and adolescents. The 24th Annual Meeting of the European Society for Paediatric Infectious Diseases; 2006 May 3-5

  BACKGROUND

MeSH Terms

Conditions

HIV Seropositivity; HIV Infections

Interventions

Sodium Chloride; Vaccines, Synthetic; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors; Vaccines, Combined; Papillomavirus Vaccines; Viral Vaccines

Limitations and Caveats

Compliance with follow up was an ongoing issue.

Results Point of Contact

• Title: Steven Hunt, MD
• Organization: Washington University

hunts@wudosis.wustl.edu

314-454-7177

Study Officials

• Steven R Hunt, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 20, 2009
• Study Start: July 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 25, 2016
• Results First Posted: July 25, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)