Cervical neoplasia. Pathogenesis, diagnosis, and management.
W R Robinson, C B Morris
https://pubmed.ncbi.nlm.nih.gov/8880203Completed
Phase 3
Age: 13Years +
FEMALE
ID00001073
A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
150
Participants Needed
40
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Who Can Participate
Age: 13Years +
FEMALE
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 40 locations
1
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
Status Unknown
2
USC CRS
Los Angeles, California, United States, 90033
Status Unknown
3
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
Status Unknown
4
Usc La Nichd Crs
Los Angeles, California, United States
Status Unknown
5
Ucsd, Avrc Crs
San Diego, California, United States, 92103
Status Unknown
6
Ucsf Aids Crs
San Francisco, California, United States
Status Unknown
7
Santa Clara Valley Med. Ctr.
San Jose, California, United States, 95128
Status Unknown
8
San Mateo County AIDS Program
San Mateo, California, United States, 94305
Status Unknown
9
Howard University Hosp., Div. of Infectious Diseases, ACTU
Washington D.C., District of Columbia, United States, 20059
Status Unknown
10
South Florida CDC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, United States
Status Unknown
11
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States
Status Unknown
12
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
Status Unknown
13
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
Status Unknown
14
Northwestern University CRS
Chicago, Illinois, United States, 60611
Status Unknown
15
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60612
Status Unknown
16
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Status Unknown
17
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
Status Unknown
18
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States, 70112
Status Unknown
19
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
Status Unknown
20
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
Status Unknown
21
Bmc Actg Crs
Boston, Massachusetts, United States, 02118
Status Unknown
22
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States, 63112
Status Unknown
23
Washington U CRS
St Louis, Missouri, United States
Status Unknown
24
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
Omaha, Nebraska, United States, 68198
Status Unknown
25
NJ Med. School CRS
Newark, New Jersey, United States
Status Unknown
26
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States, 14215
Status Unknown
27
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States, 10003
Status Unknown
28
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Status Unknown
29
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, United States, 10021
Status Unknown
30
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
Status Unknown
31
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
Status Unknown
32
Unc Aids Crs
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
33
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States, 27710
Status Unknown
34
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Status Unknown
35
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
36
University of Washington AIDS CRS
Seattle, Washington, United States, 98104
Status Unknown
37
UW School of Medicine - CHRMC
Seattle, Washington, United States
Status Unknown
38
Puerto Rico-AIDS CRS
San Juan, Puerto Rico
Status Unknown
39
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico
Status Unknown
40
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
Mbeya, Tanzania
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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