HIV Infections Clinical Trial
Official title:
A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
NCT number | NCT00001073 |
Other study ID # | ACTG 293 |
Secondary ID | 11269 |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Est. completion date | March 2001 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | March 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 13 Years and older |
Eligibility | Inclusion Criteria 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. Exclusion Criteria 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. |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Puerto Rico-AIDS CRS | San Juan | |
Puerto Rico | San Juan City Hosp. PR NICHD CRS | San Juan | |
Tanzania | Mbeya Med. Research Program, Mbeya Referral Hosp. CRS | Mbeya | |
United States | Johns Hopkins Adult AIDS CRS | Baltimore | Maryland |
United States | Alabama Therapeutics CRS | Birmingham | Alabama |
United States | Bmc Actg Crs | Boston | Massachusetts |
United States | SUNY - Buffalo, Erie County Medical Ctr. | Buffalo | New York |
United States | Unc Aids Crs | Chapel Hill | North Carolina |
United States | Northwestern University CRS | Chicago | Illinois |
United States | Rush Univ. Med. Ctr. ACTG CRS | Chicago | Illinois |
United States | Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease | Chicago | Illinois |
United States | The Ohio State Univ. AIDS CRS | Columbus | Ohio |
United States | Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina |
United States | South Florida CDC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida |
United States | Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii |
United States | Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana |
United States | Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida |
United States | UCLA CARE Center CRS | Los Angeles | California |
United States | USC CRS | Los Angeles | California |
United States | Usc La Nichd Crs | Los Angeles | California |
United States | Univ. of Miami AIDS CRS | Miami | Florida |
United States | Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU | New Orleans | Louisiana |
United States | Tulane/LSU Maternal/Child CRS | New Orleans | Louisiana |
United States | Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York |
United States | Memorial Sloan-Kettering Cancer Ctr. | New York | New York |
United States | NY Univ. HIV/AIDS CRS | New York | New York |
United States | NJ Med. School CRS | Newark | New Jersey |
United States | Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. | Omaha | Nebraska |
United States | Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania |
United States | Univ. of Rochester ACTG CRS | Rochester | New York |
United States | St. Louis ConnectCare, Infectious Diseases Clinic | Saint Louis | Missouri |
United States | Washington U CRS | Saint Louis | Missouri |
United States | Ucsd, Avrc Crs | San Diego | California |
United States | Ucsf Aids Crs | San Francisco | California |
United States | Santa Clara Valley Med. Ctr. | San Jose | California |
United States | San Mateo County AIDS Program | San Mateo | California |
United States | University of Washington AIDS CRS | Seattle | Washington |
United States | UW School of Medicine - CHRMC | Seattle | Washington |
United States | SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York |
United States | Howard University Hosp., Div. of Infectious Diseases, ACTU | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States, Puerto Rico, Tanzania,
Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. Review. — View Citation
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