se of Gardasil to prevent Cervical Cancer in patients with HIV infection taking antiretroviral drugs

Phase 3

• Conditions: Cancer

• Registration Number: PACTR202003634132762

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 536

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified