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NCT ID: NCT00023452 Completed - Tuberculosis Clinical Trials

Three Months of Weekly Rifapentine and Isoniazid for M. Tuberculosis Infection

PREVENT TB
Start date: June 2001
Phase: Phase 3
Study type: Interventional

Open-label, multi-center, Phase III clinical trial to compare the effectiveness and tolerability of a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) to the effectiveness of a nine-month (270-dose)regimen of daily isoniazid (9INH) to prevent tuberculosis (TB) among high-risk tuberculin skin-test reactors, including children and HIV-infected persons, who require treatment of latent TB infection (LTBI).

NCT ID: NCT00022672 Completed - Breast Cancer Clinical Trials

A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer

Start date: January 2001
Phase: Phase 3
Study type: Interventional

This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

NCT ID: NCT00021255 Completed - Breast Neoplasms Clinical Trials

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

Start date: April 2001
Phase: Phase 3
Study type: Interventional

Primary objective: - Compare disease-free survival in women with HER2-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin. Secondary objective: - Compare overall survival of patients treated with these regimens. - Compare the toxic effects (including cardiac) of these regimens in these patients. - Compare quality of life of patients treated with these regimens. - Compare pathologic and molecular markers for predicting efficacy of these regimens in these patients. - For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in patients treated with these regimens.

NCT ID: NCT00017719 Completed - HIV Infections Clinical Trials

Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy

Start date: May 2002
Phase: Phase 3
Study type: Interventional

The best anti-HIV treatment regimen for pregnant women is not known. Protease inhibitors (PIs) are often used, but they have side effects that may be harmful for pregnant women. It is not known if treatment regimens that do not include PIs are as effective in pregnant women as those that include PIs. This trial will compare two anti-HIV treatment plans, one with and one without PIs, in women who start HIV treatment during pregnancy. The study will evaluate the effects of the anti-HIV drugs on the developing infant and prevention of mother-to-child HIV transmission during pregnancy.

NCT ID: NCT00012389 Completed - Colorectal Cancer Clinical Trials

Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer

Start date: December 2000
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer.

NCT ID: NCT00011037 Completed - HIV Infections Clinical Trials

ALVAC-HIV vCP1452 Alone and Combined With MN rgp120

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test how the body's immune system responds to the vaccine ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN rgp120. HIV infection and AIDS have no cure, in spite of recent advances in anti-HIV drugs. Many worldwide populations cannot afford the antiviral treatments for infected people. HIV vaccines offer hope for disease prevention. In this trial, 2 experimental HIV vaccines called ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti, Brazil, Peru, and Trinidad and Tobago. The study will determine how volunteers' immune systems respond to the vaccines. (This protocol has been changed by adding new international sites.)

NCT ID: NCT00009737 Completed - Colorectal Cancer Clinical Trials

A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

Start date: November 1998
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-FU 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

NCT ID: NCT00007202 Completed - HIV Infections Clinical Trials

Safety and Effectiveness of a Three-Drug Combination Treatment for Recently Infected or Converted HIV Patients

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and effectiveness of stavudine (d4T), didanosine (ddI), and BMS-232632 when given early in the course of HIV infection. Acute HIV infection may develop in patients that are exposed to the HIV virus. Following infection, the viral load (level of HIV in the blood) rises rapidly over the next few days to weeks. It is not known which is the best treatment in patients with very early HIV infection. Researchers believe these patients may respond well to strong early treatment. A combination consisting of enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632, will be tested.

NCT ID: NCT00005918 Completed - HIV Infections Clinical Trials

Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients

Start date: June 2000
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).

NCT ID: NCT00005062 Completed - Lung Cancer Clinical Trials

Radiation Therapy in Patients With Limited-Stage Small Cell Lung Cancer in Complete Remission

Start date: September 1999
Phase: Phase 3
Study type: Interventional

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and prevent the spread of cancer to the brain. It is not yet known if standard-dose radiation therapy is more effective than high-dose radiation therapy in preventing the spread of limited-stage small cell lung cancer cells to the brain. PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with limited-stage small cell lung cancer in complete remission.