Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Public ClinicalTrials.gov record NCT00001073. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00001073
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Feb 28, 2001
- Last update posted
- Nov 3, 2021
Ends 2001
United States locations
- U.S. sites
- 37
- U.S. states
- 18
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Therapeutics CRS | Birmingham | Alabama | 35294 | — |
| USC CRS | Los Angeles | California | 90033 | — |
| UCLA CARE Center CRS | Los Angeles | California | 90095 | — |
| Usc La Nichd Crs | Los Angeles | California | — | — |
| 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 | — |
| Howard University Hosp., Div. of Infectious Diseases, ACTU | Washington D.C. | District of Columbia | 20059 | — |
| South Florida CDC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida | — | — |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | — | — |
| Univ. of Miami AIDS CRS | Miami | Florida | 33136 | — |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816 | — |
| 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 | — | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202 | — |
| Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU | New Orleans | Louisiana | 70112 | — |
| Tulane/LSU Maternal/Child CRS | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | — |
| Bmc Actg Crs | Boston | Massachusetts | 02118 | — |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis | Missouri | 63112 | — |
| Washington U CRS | St Louis | Missouri | — | — |
| Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. | Omaha | Nebraska | 68198 | — |
| NJ Med. School CRS | Newark | New Jersey | — | — |
| SUNY - Buffalo, Erie County Medical Ctr. | Buffalo | New York | 14215 | — |
| 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 | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York | — | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 275997215 | — |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | — |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | — | — |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | 19104 | — |
| University of Washington AIDS CRS | Seattle | Washington | 98104 | — |
| UW School of Medicine - CHRMC | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001073, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 3, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001073 live on ClinicalTrials.gov.