HIV InfectionsPhase 3NCT00000758
A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women
A Phase 3 study testing Fluorouracil in people with HIV Infections and Cervix, Dysplasia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in 2 countries.
Trial summary
To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- HIV Infections, Cervix, Dysplasia
- What is being tested?
- Fluorouracil
- How many people
- 158 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Start not givento Apr 1998
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Antiretrovirals (AZT, ddI, ddC) and immunomodulators (interferon and interleukin).
- Prophylaxis or treatment for opportunistic infections.
- Vaginal antifungal agents or other indicated vaginal medications (although not permitted on day of fluorouracil application).
- Contraceptives.
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- Acyclovir (prophylaxis or treatment) in patients with a history of primary or recurrent genital herpes.
- Patients must have:
- HIV infection.
- Prior cervical dysplasia (grade II or III cervical intraepithelial neoplasia) successfully treated with an ablative procedure within the past 12 weeks.
- Patients less than 18 years of age must have consent of parent or guardian.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Untreated or persistent vaginal or vulvar dysplasia.
- Colposcopy or biopsy inconclusive or positive for dysplasia.
- Active genital ulcerative disease such as syphilitic chancre or herpes ulcer.
- Adenocarcinoma in situ.
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- Concurrent Medication:
- Excluded:
- Cytotoxic chemotherapy for malignancy.
- High-dose steroids (> 10 mg/day prednisone or its steroid equivalent).
- Patients with the following prior conditions are excluded:
- Malignancy requiring cytotoxic chemotherapy within the 3 months prior to study entry.
- Prior hysterectomy.
- History of allergic reaction or severe hypersensitivity to fluorouracil.
- Prior Medication:
- Excluded:
- Fluorouracil (systemic or topical) within 3 months prior to study entry.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States19 sites
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Bmc Actg Crs
Boston, Massachusetts, 02118
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215
Unc Aids Crs
Chapel Hill, North Carolina, 27599
Northwestern University CRS
Chicago, Illinois, 60611
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 60637
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201
Usc La Nichd Crs
Los Angeles, California, 90033
Univ. of Miami AIDS CRS
Miami, Florida, 33136
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021
NJ Med. School CRS
Newark, New Jersey, 07103
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
UW School of Medicine - CHRMC
Seattle, Washington, 98122
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457
Puerto Rico2 sites
Puerto Rico-AIDS CRS
San Juan, 00936
San Juan City Hosp. PR NICHD CRS
San Juan, 00936
About this study
To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function.
Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.
Read the detailed description
Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.
Patients are randomized to receive either intravaginal fluorouracil or no treatment (observation only). Fluorouracil cream is self-administered via applicator at biweekly intervals for 6 months. Patients are evaluated for recurrent cervical dysplasia by cytology and colposcopy with or without biopsy.
- Conditions
- HIV Infections, Cervix, Dysplasia
- Being tested
- Fluorouracil
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Fluorouracil, Cervix Dysplasia, Cervix Diseases
- Medical subject headings
- HIV Infections, Uterine Cervical Dysplasia, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Uterine Cervical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorouracilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionApr 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Enrolment
- 158 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Maiman M, Study chairWatts DH, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000758
- Sponsor's protocol ID
- ACTG 200
- Other IDs
- 11176
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. doi: 10.1016/s0889-8588(05)70391-9.
PubMed 8880203Maiman M, Watts DH, Andersen J. A phase three randomized trial of topical vaginal 5-fluorouracil maintenance therapy versus observation after standard treatment for high grade cervical dysplasia in HIV-infected women: ACTG 200. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:155 (abstract no 466)
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women
- ClinicalTrials.gov ID
- NCT00000758
- Acronym / sponsor ID
- ACTG 200
- Conditions
- HIV Infections, Cervix, Dysplasia
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Fluorouracil, Cervix Dysplasia, Cervix Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Hoffmann-La Roche
- Study completion
- Apr 1998 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function.
Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.
Detailed description
Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.
Patients are randomized to receive either intravaginal fluorouracil or no treatment (observation only). Fluorouracil cream is self-administered via applicator at biweekly intervals for 6 months. Patients are evaluated for recurrent cervical dysplasia by cytology and colposcopy with or without biopsy.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Antiretrovirals (AZT, ddI, ddC) and immunomodulators (interferon and interleukin).
- Prophylaxis or treatment for opportunistic infections.
- Vaginal antifungal agents or other indicated vaginal medications (although not permitted on day of fluorouracil application).
- Contraceptives.
- Acyclovir (prophylaxis or treatment) in patients with a history of primary or recurrent genital herpes.
Key exclusion criteria (17 listed)
- Untreated or persistent vaginal or vulvar dysplasia.
- Colposcopy or biopsy inconclusive or positive for dysplasia.
- Active genital ulcerative disease such as syphilitic chancre or herpes ulcer.
- Adenocarcinoma in situ.
- Cytotoxic chemotherapy for malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorouracil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 8880203Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. doi: 10.1016/s0889-8588(05)70391-9.
- BackgroundMaiman M, Watts DH, Andersen J. A phase three randomized trial of topical vaginal 5-fluorouracil maintenance therapy versus observation after standard treatment for high grade cervical dysplasia in HIV-infected women: ACTG 200. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:155 (abstract no 466)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maiman M study chair
Watts DH study chair
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluorouracil in people with HIV Infections and Cervix, Dysplasia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000758, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.