Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women (VICAR2)
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus.
Hypothesis: LEEP will be more effective than cryotherapy in removing CIN 2/3 lesions in HIV positive women in South Africa
調査の概要
詳細な説明
Cervical cancer is the most common cancer in HIV positive women. This is due to immunosuppression and lack of organized and effective screening and treatment programs in Africa. Other screening and treatment modalities need to be evaluated in resource limited countries as there is not capacity in most of these countries to implement a cytology/histology based program. The treatment modality of cryotherapy is easy to train and perform and can be done by a nurse. LEEP requires significant training usually doctors and skills in administering local anaesthetic. This study compares the two modalities of cryotherapy vs LEEP in a randomized controlled study in HIV positive women in South Africa.
A. PRIMARY AIMS (S.A.):
- To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
- To determine the utility of subsequent HPV DNA testing as a marker of effective treatment following the treatment of CIN 2/3 among HIV-seropositive women.
- To compare the safety of cryotherapy versus LLETZ in HIV seropositive women.
SECONDARY AIMS:
1. To describe HIV disease status (CD4, HIV viral load), demographics, and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.
3. To determine the cervical disease recurrence rates with cryotherapy and LLETZ.
4. To evaluate the relationship between HIV status, demographics, HPV, and sexual behavior with the clearance of cervical disease at the ectocervical and endocervical margins in HIV seropositive women.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Gauteng
-
Johannesburg、Gauteng、南アフリカ、2092
- Helen Joseph Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Women 18-65 years of age
- Not menstruating (if menstruating, the patient can be screened at another date)
- Able to sign consent
- Able to follow the study protocol
- HIV positive (by two different criteria; either 2 different rapid HPV tests of different manufacturers, a HIV viral load ≥5,000,ELISA, Western blot documented in VICAR 1)
- Participant with histology-proven CIN 2 or 3 disease
Exclusion Criteria:
- Pregnant
- Clinically active sexually transmitted disease determined by clinical history and/or physical exam (may participate after adequate treatment by syndromic treatment management)
- Known and previous treatment for high grade squamouse intraepithelial lesion by any method (cryotherapy, LLETZ or cone biopsy)
- Previous hysterectomy with removal of the cervix
- Significant medical illness/mental illness that the investigator feels would prevent the participant from complying with the protocol or place the participant at medical risk
Cervical dysplastic lesions that are not appropriate for cryotherapy, defined as the following:
- Lesion is greater than ≥75% cervix
- Lesion entering into the cervical canal and the complete lesion cannot be visualized
- Presence of abnormal vasculature
- Lesion bigger that the cryotherapy probe
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Arm B
LEEP treatment of CIN 2/3 cervical lesion in HIV positive women (standard of Care)
|
The cervix is anaesthetized with lidocaine and then a electric loop is applied to the cervical lesion which is cut with one pass.
The LEEP machine used is the automatic Finesse Machine.
他の名前：
|
|
実験的：Arm A
Cryotherapy treatment of CIN 2/3 cervical lesions
|
This is involves freezing the lesions with a cryo gun using Nitrous Oxide for 3 minutes-- wait 5 minutes and then refreezing for 3 more minutes.
This procedure uses the Wallach cryogun
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compare efficacy of cryotherapy and LEEP
時間枠：1 year
|
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The ability to use Human Papillomavirus as the measure of treatment success
時間枠：1 year
|
To determine the utility of subsequent HPV DNA testing as a marker of effective treatment following the treatment of CIN 2/3 among HIV-seropositive women.
|
1 year
|
|
To compare the safety of cryotherapy versus LLETZ in HIV seropositive women
時間枠：1 month, 6 months and 12 months
|
To compare the safety of cryotherapy versus LLETZ in HIV seropositive women by evaluating adverse events as measured by the Division of AIDS toxicity table 2004 (revised August 2010)
|
1 month, 6 months and 12 months
|
|
Describe factors associated with successful treatment of CIN 2/3
時間枠：1 year
|
To describe HIV disease status (CD4, HIV viral load), demographics, tissue margins and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.
|
1 year
|
|
To determine the cervical disease recurrence rates with cryotherapy and LLETZ.
時間枠：6 months and 12 months
|
To determine the cervical disease recurrence rates with cryotherapy and LLETZ at 6 months and 12 months by colposcopy
|
6 months and 12 months
|
協力者と研究者
捜査官
- 主任研究者：Cynthia S Firnhaber, MD、University of Witwatersrand, South Africa
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- ZA.09.0265
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。