HIV PositiveNCT00941889

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

A study testing Saline and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine in people with HIV Positive and Anal Condylomata, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Positive, Anal Condylomata, Anal Warts
What is being tested?: Saline and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Jul 2007to Jul 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥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.

Who cannot join

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;

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University in St. Louis, Section of Colon Rectal Surgery
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata

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.

Read the detailed description

A quadrivalent human papilloma virus (HPV) vaccine called Gardasil had recently (at start of study) been developed and approved by the FDA for the prevention of cervical HPV infection and cervical cancer, which is associated with infection from this virus. It is unknown whether the same vaccine could also be of benefit in treating anogenital warts, which are caused by the same virus. This is an important and clinically relevant question which needs to be answered. Anal warts have a high prevalence and recurrence and usually require extended lengths of treatment and follow-up, especially in the HIV population. At times, treatment of anal warts requires multiple surgeries to excise them if the burden of disease is high. Therefore, this disease represents a significant expense to patients and the health care system.

Further, the HPV virus that causes anal warts has been associated with anal cancer and with its preliminary lesion known as anal intraepithelial neoplasia (AIN). This study touches on two important, relevant and costly healthcare issues: finding a better treatment for the most common sexually transmitted disease in our country, and helping to prevent anal cancer, which is often a fatal disease.

Conditions: HIV Positive, Anal Condylomata, Anal Warts, HIV Infections
Being tested: Saline, Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Keywords: HIV, HPV, Anal condylomata, Vaccine, HIV positive patients, Anal condylomata or anal warts
Medical subject headings: HIV Seropositivity, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SalineDrug
0.5 ml
Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant VaccineDrug
Also called GARDASIL
0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.

Study groups in NCT00941889
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Jul 2011

First posted20 Jul 2009 (estimated)
Study startJul 2007
Primary completionJul 2011
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for HIV PositiveStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00941889
Sponsor's protocol ID: HRPO 07-0648
Status last verified: Jun 2016
First submitted: 16 Jul 2009
Last updated: 25 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: No outcomes data were collected or analyzed due to lack of participant follow-up.

Publications

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.
PubMed 19211451
Human papillomavirus vaccines. WHO position paper. Wkly Epidemiol Rec. 2009 Apr 10;84(15):118-31. No abstract available. English, French.
PubMed 19360985
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.
PubMed 19211446
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.
PubMed 19326612
Stanley M. The epidemiology and burden of HPV disease. Nurs Times. 2008 Sep 9-15;104(36):38-40.
PubMed 18822547
Gross G. Impact of prophylactic human papillomavirus vaccines on dermatology and venereology. G Ital Dermatol Venereol. 2008 Aug;143(4):259-65.
PubMed 18833082
Herbert J, Coffin J. Reducing patient risk for human papillomavirus infection and cervical cancer. J Am Osteopath Assoc. 2008 Feb;108(2):65-70.
PubMed 18303060
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.
PubMed 18512537
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.
PubMed 16886157
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.
PubMed 12543621
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.
PubMed 12516848
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.
PubMed 15863374
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Human Papillomavirus Vaccination on Recurrence Rates in HIV Positive Patients Treated for Anal Condylomata
ClinicalTrials.gov ID: NCT00941889
Acronym / sponsor ID: HRPO 07-0648
Conditions: HIV Positive, Anal Condylomata, Anal Warts, HIV Infections
Keywords: HIV, HPV, Anal condylomata, Vaccine, HIV positive patients, Anal condylomata or anal warts
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: Jul 2007
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 20 Jul 2009 (estimated)
Results: Posted 25 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: SalinePatients 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.
Gardasil	Active comparator	Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant VaccineThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

≥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.

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Saline0.5 ml	Drug	Placebo
Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant VaccineAlso: GARDASIL0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.	Drug	Gardasil

Primary outcome

The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups.
Time frame: Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment
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.

Results and safety

Results posted to the registry on 25 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	17	5
Gardasil Group	15	3

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

Time frame: Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment. Number. Unit: participants

Measure	Placebo Group n = 5	Gardasil Group n = 7
Value	1	1

Population analysed: Five patients from the placebo group and seven patients from the gardasil group completed all three injections per the protocol. The remaining patients did not complete study-required follow-up and therefore could not be analyzed. One patient from the Gardasil Group and one patient from the placebo group met the outcome measure of recurrence.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 0	0 of 0	Not reported
Treatment Group	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Compliance with follow up was an ongoing issue.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19211451StatBite: 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.
Background: PubMed 19360985Human papillomavirus vaccines. WHO position paper. Wkly Epidemiol Rec. 2009 Apr 10;84(15):118-31. No abstract available. English, French.
Background: PubMed 19211446Chitale 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.
Background: PubMed 19326612Gillespie 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.
Background: PubMed 18822547Stanley M. The epidemiology and burden of HPV disease. Nurs Times. 2008 Sep 9-15;104(36):38-40.
Background: PubMed 18833082Gross G. Impact of prophylactic human papillomavirus vaccines on dermatology and venereology. G Ital Dermatol Venereol. 2008 Aug;143(4):259-65.
Background: PubMed 18303060Herbert J, Coffin J. Reducing patient risk for human papillomavirus infection and cervical cancer. J Am Osteopath Assoc. 2008 Feb;108(2):65-70.
Background: PubMed 18512537Dowling 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.
Background: PubMed 16886157Dunne 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.
Background: PubMed 12543621Winer 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.
Background: PubMed 12516848Vukasin 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.
Background: PubMed 15863374Villa 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.
Individual participant dataSharing planned: No. No outcomes data were collected or analyzed due to lack of participant follow-up.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven R Hunt, MD principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups. (time frame: Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00941889, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.