Anal Condylomata, Anal Warts, HIV Infections, HIV Positive
Conditions
Keywords
HIV, HPV, Anal condylomata, Vaccine, HIV positive patients, Anal condylomata or anal warts
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.
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.
Interventions
DRUGSaline
0.5 ml
0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups. | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited during office visits.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients in this group received placebo of saline at initial date, 2 months and 6 months after enrollment. | 17 |
| Gardasil Patients in this group received Gardasil injection at initial date, 2 months and 6 months after enrollment. | 15 |
| Total | 32 |
Baseline characteristics
| Characteristic | Gardasil | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 17 Participants | 32 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 13 | 36 years STANDARD_DEVIATION 10 | 37 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 15 participants | 17 participants | 32 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Follow up evaluation after treatment at 1, 3, 6, 9. 12, 15, 18 months after initial treatment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Group | The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups. | 1 participants |
| Gardasil Group | The Primary Endpoint of This Study is Persistence and Recurrence of Anal Warts as Compared Between the Experimental and Control Groups. | 1 participants |