N/A
N=32
The Effect of HPV Vaccination on Recurrence Rates in HIV Patients With Condylomata
HIV Positive · Anal Condylomata · Anal Warts · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00941889 ↗Enrolled (actual)
32
Serious AEs
—
Results posted
Jul 2016
Primary outcome: Primary: The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups. — 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Saline (Drug); Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups. |
1; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age;
- HIV positive status;
- CD4 > 200 and viral RNA 350 if not on HARRT;
- the presence of anal warts that require surgical excision/ablation.
Exclusion Criteria
- CD4 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.
Data sourced from ClinicalTrials.gov (NCT00941889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.