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NCT ID: NCT00121979 Completed - HIV Infections Clinical Trials

Study Comparing Racivir and Lamivudine in Treatment-Experienced HIV Subjects

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

Racivir ® (RCV) is an experimental drug which means it is not approved for use by the United States Food and Drug Administration (FDA), but it can be used in research studies like this one. RCV (Racivir®) is part of a class of drugs known as "Nucleoside Reverse Transcriptase Inhibitors" (NRTIs), which are intended to block a further increase in the amount of HIV virus in the body. Laboratory research suggests that RCV (Racivir®) may be effective in patients who have developed resistance to other NRTIs, particularly 3TC (lamivudine, Epivir®). However, a study of RCV (Racivir®) has not been done with patients who have previously been treated with other HAART (Highly Active Antiretroviral Therapy -- taking multiple HIV drugs at once) medications including 3TC (lamivudine, Epivir®). The purpose of this study is to evaluate the safety and effectiveness of RCV (Racivir®) when used together with other HIV drugs in people who have previously been treated with 3TC (lamivudine, Epivir®) and are failing with their current HAART treatments. This study will include a total of 60 HIV infected, HAART-experienced subjects currently receiving 3TC (lamivudine, Epivir®) as part of their HAART therapy. The study will take place at approximately 11 study sites in the US and Latin America.

NCT ID: NCT00110877 Completed - HIV Infection Clinical Trials

TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

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

Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.

NCT ID: NCT00106574 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

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

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

NCT ID: NCT00099203 Terminated - Pain Clinical Trials

A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

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

This 2 arm study will compare the efficacy of intravenous Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 and then every 3-4 weeks) or zoledronic acid (4mg iv on day 1 and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00099177 Terminated - Pain Clinical Trials

A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

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

This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00098059 Completed - Herpes Simplex Clinical Trials

Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

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

This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.

NCT ID: NCT00098046 Completed - Herpes Zoster Clinical Trials

Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection

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

Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age.

NCT ID: NCT00090753 Completed - Anemia Clinical Trials

A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

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

This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.

NCT ID: NCT00088530 Completed - Clinical trials for Lymphoma, Non-Hodgkin

BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)

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

BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).

NCT ID: NCT00077623 Completed - Anemia Clinical Trials

A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.

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

This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.