HIV InfectionsPhase 3NCT00001073
Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
A Phase 3 study testing Isotretinoin in people with HIV Infections and Cervix, Dysplasia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 40 sites in 3 countries.
Trial summary
The purpose of this study is to see if it is safe and effective to give isotretinoin to HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous. Cervical tumors are found in both HIV-infected and HIV-negative women. 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?
- Isotretinoin
- How many people
- 150 participants
- Where
- 40 sitesin 3 countries
- Study dates
- Start not givento Mar 2001
- 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
- You may be eligible for this study if you:
- Are an HIV-positive female.
- Are at least 13 years old. (Need consent of parent or guardian if under 18.)
- Have cervical tumors, as determined by a biopsy performed by a doctor.
- Agree to use both condoms and the pill during the study.
Who cannot join
- You will not be eligible for this study if you:
- Have received certain cancer therapies (such as chemotherapy) within the past 3 or 4 months.
- Have had a hysterectomy (uterus removed) within the past 4 months.
- Are taking tetracycline or Vitamin A.
- Have taken certain medications. (Approved anti-HIV drugs and medications to prevent AIDS-related opportunistic infections are okay.)
- Are pregnant.
Trial locations and contacts
40 sites in 3 countries.
40 sites in 3 countries
United States37 sites
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Alabama Therapeutics CRS
Birmingham, Alabama, 35294
Bmc Actg Crs
Boston, Massachusetts, 02118
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215
Unc Aids Crs
Chapel Hill, North Carolina, 275997215
Northwestern University CRS
Chicago, Illinois, 60611
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois
The Ohio State Univ. AIDS CRS
Columbus, Ohio
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710
South Florida CDC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida
USC CRS
Los Angeles, California, 90033
UCLA CARE Center CRS
Los Angeles, California, 90095
Usc La Nichd Crs
Los Angeles, California
Univ. of Miami AIDS CRS
Miami, Florida, 33136
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, 70112
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 70112
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021
NJ Med. School CRS
Newark, New Jersey
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, 68198
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Ucsd, Avrc Crs
San Diego, California, 92103
Ucsf Aids Crs
San Francisco, California
Santa Clara Valley Med. Ctr.
San Jose, California, 95128
San Mateo County AIDS Program
San Mateo, California, 94305
University of Washington AIDS CRS
Seattle, Washington, 98104
UW School of Medicine - CHRMC
Seattle, Washington
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112
Washington U CRS
St Louis, Missouri
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, 20059
Puerto Rico2 sites
Puerto Rico-AIDS CRS
San Juan
San Juan City Hosp. PR NICHD CRS
San Juan
About this study
Official title: A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
The purpose of this study is to see if it is safe and effective to give isotretinoin to HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous.
Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected women are at a greater risk, and often their tumors become cancerous more quickly than those in HIV-negative women. Isotretinoin may be able to prevent this from happening. However, since these tumors tend to disappear over time, many doctors are hesitant to give their patients isotretinoin since this drug causes birth defects. This study looks at whether it is better to treat cervical tumors in HIV-infected women or to wait and see if they will disappear by themselves.
Read the detailed description
Cervical neoplasia is frequently seen in HIV-infected women, apparently resulting from immunosuppression and common risk factors, including sexual behavior patterns. In HIV seronegative women, progression of preinvasive neoplasia is relatively slow, and up to 40 percent of low grade squamous intraepithelial lesions (grade I CIN/HPV-associated changes) regress to a normal appearance over time. Many clinicians have opted not to treat CIN I/HPV-associated changes due to this high spontaneous regression rate. Currently, retinoids, principally isotretinoin, are the most consistently effective medical therapy for CIN/HPV-associated changes, but use of isotretinoin in HIV-infected patients has not been extensively documented. (AS PER AMENDMENT 6/10/97)
Patients are randomized to receive oral isotretinoin for 6 months or be observed only for 6 months, with 12 additional months of follow-up. [AS PER AMENDMENT 7/23/99: Follow-up time has been decreased to 9 months from the last patient enrolled.]
- Conditions
- HIV Infections, Cervix, Dysplasia
- Being tested
- Isotretinoin
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Cervix Dysplasia, Cervix Diseases, Isotretinoin, Cervical Intraepithelial Neoplasia, Cervix Neoplasms, Keratolytic Agents
- Medical subject headings
- HIV Infections, Uterine Cervical Dysplasia, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Uterine Cervical Diseases, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
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 completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Enrolment
- 150 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- William Robinson, Study chairMitchell Maiman, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001073
- Sponsor's protocol ID
- ACTG 293
- Other IDs
- 11269
- 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 8880203
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 Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
- ClinicalTrials.gov ID
- NCT00001073
- Acronym / sponsor ID
- ACTG 293
- Conditions
- HIV Infections, Cervix, Dysplasia
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Cervix Dysplasia, Cervix Diseases, Isotretinoin, Cervical Intraepithelial Neoplasia, Cervix Neoplasms, Keratolytic Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Mar 2001 (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.
The purpose of this study is to see if it is safe and effective to give isotretinoin to HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous.
Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected women are at a greater risk, and often their tumors become cancerous more quickly than those in HIV-negative women. Isotretinoin may be able to prevent this from happening. However, since these tumors tend to disappear over time, many doctors are hesitant to give their patients isotretinoin since this drug causes birth defects. This study looks at whether it is better to treat cervical tumors in HIV-infected women or to wait and see if they will disappear by themselves.
Detailed description
Cervical neoplasia is frequently seen in HIV-infected women, apparently resulting from immunosuppression and common risk factors, including sexual behavior patterns. In HIV seronegative women, progression of preinvasive neoplasia is relatively slow, and up to 40 percent of low grade squamous intraepithelial lesions (grade I CIN/HPV-associated changes) regress to a normal appearance over time. Many clinicians have opted not to treat CIN I/HPV-associated changes due to this high spontaneous regression rate. Currently, retinoids, principally isotretinoin, are the most consistently effective medical therapy for CIN/HPV-associated changes, but use of isotretinoin in HIV-infected patients has not been extensively documented. (AS PER AMENDMENT 6/10/97)
Patients are randomized to receive oral isotretinoin for 6 months or be observed only for 6 months, with 12 additional months of follow-up. [AS PER AMENDMENT 7/23/99: Follow-up time has been decreased to 9 months from the last patient enrolled.]
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Are an HIV-positive female.
- Are at least 13 years old. (Need consent of parent or guardian if under 18.)
- Have cervical tumors, as determined by a biopsy performed by a doctor.
- Agree to use both condoms and the pill during the study.
Key exclusion criteria (6 listed)
- Have received certain cancer therapies (such as chemotherapy) within the past 3 or 4 months.
- Have had a hysterectomy (uterus removed) within the past 4 months.
- Are taking tetracycline or Vitamin A.
- Have taken certain medications. (Approved anti-HIV drugs and medications to prevent AIDS-related opportunistic infections are okay.)
- Are pregnant.
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 |
|---|---|---|
| Isotretinoin | 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.
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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.
William Robinson study chair
Mitchell Maiman study chair
40 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isotretinoin in people with HIV Infections and Cervix, Dysplasia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 40 sites in 3 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 5 inclusion and 6 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 40 sites in United States, Puerto Rico, Tanzania. 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 NCT00001073, which also lists 1 linked publication.
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.