Cancer
Conditions
Interventions
Vaccine
Sodium chloride
Sponsors
AIDS Malignancy Consortium
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. HIV-1 infection, documented by one of the following any time prior to study entry: • Any licensed rapid HIV test. • HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit. And confirmed by one of the following: • Licensed western blot. • Second antibody test by a method other than the initial rapid HIV and/or E/CIA. • HIV-1 antigen. • Plasma HIV-1 RNA viral load. • Documentation of receipt of antiretroviral therapy. 2. HPV positive by the GeneXpert hrHPV assay with HPV16, HPV 18/45, or HPV31/33/35/52/58 detected. 3.Age = 25 years. 4. Receipt of ART for at least 180 days prior to randomization. 5. Participants of childbearing potential, defined as a sexually mature woman who: (1) has not undergone a hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a negative urine or serum pregnancy test within 3 weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception or hormonalcontraception), delaying pregnancy for at least 12 months and ideally for the duration of the study 6. If the participant is of childbearing potential, she should be at least 3 months postpartum. 7. Karnofsky score >70% 8.Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: 1. Current STI requiring treatment (women may participate after adequate treatment, at the discretion of the treating provider). 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gardasil or Gardasil 9. 3. Uncontrolled intercurrent illness that would limit compliance with study requirements. 4. Prior hysterectomy with removal of the cervix. 5. Prior treatment for cervical HSIL. 6. Prior history of cervical, vulvar, or vaginal cancer. 7. Cervical, vulvar, or vaginal lesions suspicious for cancer based on clinical appearance (e.g. necrotic, ulcerated, and/or fungating masses), unless biopsies show no invasive cancer. 8. Known bleeding diathesis. 9. Prior HPV vaccination. 10. Current or planned use of anticoagulants other than aspirin or non-steroidal antiinflammatory agents. 11. Documentation of WHO Clinical Stage 3 or 4 condition within 6 months of entry. 12. CD4 count <200 cells/mm3 within 6 months of entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cervical HSIL or invasive cervical cancer diagnosed after the week 4 visit through week 52 post-randomization.;Primary endpoint Cervical HSIL or invasive cervical cancer diagnosed after the week 4 visit through week 52 post-randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints To describe occurrence of cervical HSIL from week 52 to week 104 • Cervical HSIL diagnosed after the week 52 visit through week 104 postrandomization To examine the predictors of sustained absence of cervical HSIL through week 104 and clearance of HPV infections after cervical treatment, including: baseline types and quantity of HPV, presence of HSIL at baseline, cryotherapy vs. LEEP, CD4+ cell count, plasma HIV-1 RNA, ART use, age, sexual behavior, and vaccination use • Cervical HSIL diagnosed after the week 4 visit through week 104, HPV DNA PCR, hrHPV testing by Xpert To compare, between study arms, incident cervical vaccine type HPV infections and cervical cytology results. • HPV DNA PCR, cervical cytology | — |
Countries
Kenya
Contacts
Public ContactJob Kisuya
Immunologist
Outcome results
None listed