CIN 2/3, HIV Infections
Conditions
Keywords
cervical cancer, CIN 2/3, 5-Fluorouracil
Brief summary
This is a single arm study on the safety, feasibility, and acceptability of adjuvant, self-administered, intravaginal 5-Fluorouracil (5-FU) following treatment for high-grade cervical precancer (CIN2/3) among women living with human immunodeficiency virus (HIV).
Interventions
DRUGIntravaginal 5-Fluorouracil (5-FU)
Participants will self-administer 2 g of 5% 5-FU intravaginally using an applicator, one night per week (every other week), on weeks 1, 3, 5, 7, 9, 11, 13, 15, for a total of 8 applications.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the inclusion criteria to participate in this study. Inclusion Criteria: 1. HIV-positive women 2. Age 18 years - 49 years at enrollment 3. Documentation of a biopsy-confirmed CIN2 or CIN3 4. Within 4-12 weeks after primary treatment for CIN2 or CIN3 5. Negative pregnancy test at screening and agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation - plus condoms) during the study duration, if of childbearing age. 6. Agree to use dual contraception if of childbearing age (hormonal method, intrauterine or implant device, or tubal ligation - plus condoms) for duration of study 7. Ability to understand and willingness to sign (or assent when applicable) informed consent
Exclusion criteria
1. HIV-negative women 2. Pregnant or planning pregnancy within the next 6 months or breastfeeding 3. Unwilling or unable to use birth control during participation in the study 4. History of invasive cervical cancer 5. Untreated vaginal or vulvar dysplasia 6. Known allergy to 5-Fluorouracil 7. History of total hysterectomy 8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient 9. Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of intravaginal 5-FU | Up to 5 months | Safety will be evaluated as type, frequency, and severity of Adverse Events (AE)s. AEs will be evaluated according to the National Institute of Health (NIH) Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event Grading Tables. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event and Grade 5 indicates death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of intravaginal 5-FU | Up to 5 months | Tolerability will be evaluated by assessing the number of participants experiencing specified adverse events (SAEs), defined as a Grade 3 or 4 toxicity that is possibly, probably, or definitely related to the study agent. |
| Adherence of intravaginal 5-FU | Up to 5 months | Adherence will be evaluated by assessing the number of participants who are confirmed to use 75% or more of the 5-FU applications. |
| Acceptability of intravaginal 5-FU | Up to 20 weeks | Responses to an acceptability questionnaire will be summarized, including means and standard deviation for responses to questions graded on a Likert scale (from 0 to 4), and proportions and 95% confidence intervals for yes/no questions. |
| Uptake of intravaginal 5-FU | Up to 20 weeks | The proportion of eligible screened participants who agree to participate in the trial and applied intravaginal 5-FU as the study defined. |
Countries
Kenya
Outcome results
None listed