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NCT ID: NCT00105079 Completed - HIV Infections Clinical Trials

GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection

Start date: April 2005
Phase: Phase 3
Study type: Interventional

This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00104403 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting

Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy

Start date: December 2004
Phase: Phase 2
Study type: Interventional

This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.

NCT ID: NCT00103844 Completed - Clinical trials for Chronic Myeloid Leukemia

Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia

Start date: February 2005
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

NCT ID: NCT00102739 Completed - Clinical trials for Purpura, Thrombocytopaenic, Idiopathic

SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)

Start date: February 2005
Phase: Phase 2
Study type: Interventional

This study is a double-blind, randomized, placebo-controlled, parallel group, repeat-dose, study conducted in two parts (Part A and Part B) examining 30, 50, and 75 mg doses of SB-497115-GR as a treatment for patients with ITP who have failed prior therapy. The study is designed to determine the proportion of patients with a platelet count =50,000/µL after 42 days. In Part B, 99 newly-recruited subjects will be randomized to one of two dosing arms in a 2:1 ratio of active:placebo. During the 6 week study period, subjects will start on placebo or active drug (50 mg) and may have a dose increase to 75 mg based upon their platelet count at day 22.

NCT ID: NCT00101998 Completed - Constipation Clinical Trials

Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

Start date: October 1, 2003
Phase: Phase 2
Study type: Interventional

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

NCT ID: NCT00101647 Completed - Clinical trials for Chronic Myelogenous Leukemia

Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia

Start date: December 2004
Phase: Phase 2
Study type: Interventional

The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.

NCT ID: NCT00101608 Completed - Bladder Cancer Clinical Trials

Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

Start date: January 2005
Phase: Phase 2
Study type: Interventional

The purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied.

NCT ID: NCT00100867 Completed - HIV Infections Clinical Trials

Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women

Start date: June 2006
Phase: N/A
Study type: Observational

In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. The purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-HIV treatment on infants born to these HIV-infected women. Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV transmission.

NCT ID: NCT00096785 Completed - Hepatitis B Clinical Trials

Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection

Start date: December 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.

NCT ID: NCT00095030 Completed - Clinical trials for Diabetes Mellitus, Type 2

Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone

Start date: February 2004
Phase: Phase 3
Study type: Interventional

The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.