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NCT ID: NCT00051831 Completed - HIV Infections Clinical Trials

Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults

Start date: October 2003
Phase: N/A
Study type: Interventional

HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.

NCT ID: NCT00051558 Completed - Osteoporosis Clinical Trials

Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis

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

Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.

NCT ID: NCT00050271 Completed - HIV Infections Clinical Trials

Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy

Start date: n/a
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if acetyl-L-carnitine (ALC) reduces pain, numbness, and tingling in the feet and legs of patients with nucleoside reverse transcriptase inhibitor (NRTI)-associated peripheral neuropathy. Another purpose is to determine if ALC is safe and tolerable in HIV patients who have taken certain anti-HIV drugs.

NCT ID: NCT00050089 Completed - HIV Infections Clinical Trials

CSP #512 - Options in Management With Anti-Retrovirals

OPTIMA
Start date: January 2001
Phase: N/A
Study type: Interventional

This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs. The first randomization will allocate patients to an intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4 drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum) of follow-up; median duration of patient follow-up is about 4 years. The target sample size is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24 VA, 19 UK and 21 Canada.

NCT ID: NCT00050011 Completed - Osteoporosis Clinical Trials

Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy

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

This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 2.5 mg daily as an adjuvant therapy.

NCT ID: NCT00048971 Completed - Colorectal Cancer Clinical Trials

Genetic Trial to Study Diarrhea in Patients With Stage III Colon Cancer Who Are Receiving Chemotherapy

Start date: April 2002
Phase: N/A
Study type: Observational

RATIONALE: Genetic testing may help predict how patients will respond to chemotherapy drugs and may help doctors plan more effective treatment with fewer side effects. PURPOSE: Genetic study to determine how genes affect the severity of diarrhea in patients with stage III colon cancer who are receiving chemotherapy.

NCT ID: NCT00048945 Completed - Chronic Hepatitis B Clinical Trials

Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B

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

The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB.

NCT ID: NCT00048022 Completed - Asthma Clinical Trials

Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma

Start date: October 25, 2002
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the anti-inflammatory action and safety of Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The research is being conducted at up to 40 clinical research sites in the US. Study participants will have a number of visits to a research site over a 4-month period.

NCT ID: NCT00048009 Completed - Asthma Clinical Trials

Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids

Start date: October 25, 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to be used in future studies, assess the efficacy and safety, and the anti-inflammatory action of the test drug in the treatment of asthmatic patients who are not currently receiving chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical research sites in the US, Mexico, and Canada. Study participants will have a number of visits to a research site over approximately a 4-month period.

NCT ID: NCT00046176 Completed - HIV Infection Clinical Trials

A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced Patients

Start date: August 26, 2002
Phase: Phase 3
Study type: Interventional

This study is a 48-week study designed to evaluate the safety and efficacy of a fixed-dose combination tablet administered once-a-day versus the individual tablets administered twice-a-day within 3-drug combination regimens in ART (antiretroviral)-experienced HIV-1 infected patients.