A clinical trial to study prevention of HPV in HIV-Positive women in India

Phase 1

Completed

• Conditions: Health Condition 1: null- 150 Female patients aged 18 years or older who have HIV-1 infection,as documented by any licensed ELISA test kit and confirmed by Western blot.

• Registration Number: CTRI/2009/091/000298
• Lead Sponsor: AIDS Malignancy Clinical Trials Consortium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Women age 18 or older.

Doucmented HIV-1 infection.

If having a nadir CD4 level less than or equal to 350, must be on HAART for at least 6 months prior to entry.

If having a nadir CD4 level greater than 350, must not be on HAART at the time of study entry.

Karnofsky performance score greater than or equal to 70 within 45 days prior to entry.

Must not be pregnant at the time of enrollment and must be willing and able to practice contraception to avoid pregnancy for the one year duration of the study.

Must not be breastfeeding a baby during the study.

Exclusion Criteria

Current or history of high-grade CIN or cervical cancer.

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.

NOTE: Routine standard of care, including hepatitis B, influenza, and tetanus vaccines are not excluded.

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 45 days prior to entry.

Inability to provide informed consent.

Allergy to yeast or any of the components of Gardasil.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Determine the proportion of participants who respond serologically to the vaccine and the kinetics of the serologic response.Timepoint: Baseline through study discontinuation.;To evaluate the effect of the vaccine on HIV viral load and CD4+/CD8+ levels.Timepoint: Baseline through study discontinuation.;To evaluate the safety of Gardasil vaccine among HIV-positive women in Chennai, India with and without prior exposure to one or more of the HPV types in the vaccine.Timepoint: Enrollment through study discontinuation.

Secondary Outcome Measures

Name	Time	Method
To determine the presence and level of CIN and the spectrum of cervical HPV types in participants.Timepoint: Baseline, 9 months and one year after vaccination.