Phase 2
N=109
Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection
Infection · Precancerous Condition
Bottom Line
View on ClinicalTrials.gov: NCT00513526 ↗Enrolled (actual)
109
Serious AEs
4.6%
Results posted
Jul 2011
Primary outcome: Primary: Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gardasil (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- AIDS Malignancy Consortium
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine |
— | — |
| PRIMARY Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline |
0.98 | — |
| PRIMARY Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline |
0.99 | — |
| PRIMARY Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline |
1.00 | — |
| PRIMARY Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline |
0.95 | — |
| SECONDARY Longitudinal Changes in CD4+ Cell Count From Baseline |
11; 9; 1 | — |
| SECONDARY Longitudinal Changes in Plasma HIV-1 RNA From Baseline |
38; 0; 0; 0 | — |
| SECONDARY HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status |
76; 933; 613; 5; 336; 146 | — |
| SECONDARY HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status |
53; 1536; 797; 5; 503; 196 | — |
| SECONDARY HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status |
83; 2005; 1225; 6; 1001; 287 | — |
| SECONDARY HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status |
53; 765; 370; 5; 181; 38 | — |
| SECONDARY Evaluate Oral Levels of Serum IgA Before and After the Vaccination Series |
— | — |
Summary
RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells.
PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria
- HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry
- HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
- Anal human papilloma virus DNA PCR-negative for either type 16 and/or type 18 within 90 days prior to entry
- If receiving antiretroviral therapy:
- Receipt of antiretroviral therapy for at least 6 months prior to entry
- No change in antiretroviral therapy within 30 days prior to entry
- CD4 cell count > 200 cells/mm³ within 90 days prior to study entry
- HIV-1 RNA 750 cells/mm³
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm³
- Creatinine clearance ≥ 60 mL/min
- AST and ALT ≤ 3 times ULN
- Total or conjugated (direct) bilirubin ≤ 2.5 times ULN
Exclusion criteria
- Serious medical or psychiatric illness, active drug or alcohol use, or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment and/or hospitalization within the past 45 days
- Allergy to yeast or any of the components of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
- Hemophilia
PRIOR CONCURRENT THERAPY:
Inclusion criteria
- See Disease Characteristics
Exclusion criteria
- Prior splenectomy
- Currently receiving anticoagulation therapy other than acetylsalicylic acid
- Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry
- Routine standard of care, including hepatitis A or B, influenza, or pneumococcal and tetanus vaccines are not excluded
- Hepatitis C co-infected patients are eligible provided no concurrent initiation of treatment for hepatitis C
- Prior receipt of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine or other HPV vaccine
Data sourced from ClinicalTrials.gov (NCT00513526). 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.