Clinical trial · Interventional
Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men
Pilot Study to Evaluate the Immunogenicity and Safety of the HPV Quadrivalent Vaccine (Gardasil) in HIV-infected Men
NCT00666107CI-TRIAL-00006469MIRB #862unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will investigate the efficacy and safety of the quadrivalent vaccine (Gardasil) against the human papilloma virus (HPV) in HIV (human immunodeficiency virus) infected males.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| HIV Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardasil | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Determine Geometric Mean Titers of anti-HPV 16 and anti-HPV 18 antibodies
- timeFrame
- nine months
- measure
- Determine percentage of subjects who seroconverted or mounted a significant serologic response to each of the 2 antigens 16 and 18
- timeFrame
- 8-9 months
- measure
- Determine how many patients, if any, develop evidence of anal HPV infection, as measured by development of a positive HPV test.
- timeFrame
- 9 months
- measure
- Determine if vaccinations will activate the subject's immune systems sufficiently that the HIV-1 viral load either increases from the baseline value, or becomes detectable and stays detectable after being undetectable at the baseline visit
- timeFrame
- nine months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male veterans * Age 18 or older * HIV-positive * Seen regularly in the ID Primary Care Clinic at the VA Long Beach Healthcare System Exclusion Criteria: * None
References
Publications (7)
- BACKGROUNDChin-Hong PV, Palefsky JM. Natural history and clinical management of anal human papillomavirus disease in men and women infected with human immunodeficiency virus. Clin Infect Dis. 2002 Nov 1;35(9):1127-34. doi: 10.1086/344057. Epub 2002 Oct 14. PMID 12384848
- BACKGROUNDFUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741. PMID 17494925
- BACKGROUNDEmeny RT, Wheeler CM, Jansen KU, Hunt WC, Fu TM, Smith JF, MacMullen S, Esser MT, Paliard X. Priming of human papillomavirus type 11-specific humoral and cellular immune responses in college-aged women with a virus-like particle vaccine. J Virol. 2002 Aug;76(15):7832-42. doi: 10.1128/jvi.76.15.7832-7842.2002. PMID 12097595
- BACKGROUNDVilla 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
- BACKGROUNDOlsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, Iversen OE, Hoye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, von Krogh G, Lehtinen M, Paavonen J, Tamms GM, Giacoletti K, Lupinacci L, Esser MT, Vuocolo SC, Saah AJ, Barr E. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine. 2007 Jun 21;25(26):4931-9. doi: 10.1016/j.vaccine.2007.03.049. Epub 2007 Apr 20. PMID 17499406
- Bower M, Powles T, Newsom-Davis T, Thirlwell C, Stebbing J, Mandalia S, Nelson M, Gazzard B. HIV-associated anal cancer: has highly active antiretroviral therapy reduced the incidence or improved the outcome? J Acquir Immune Defic Syndr. 2004 Dec 15;37(5):1563-5. doi: 10.1097/00126334-200412150-00004.