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Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

2014-08-27 03:59:17 | BioPortfolio

Summary

To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses. To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgene's pivotal placebo-controlled study.

Description

Patients are randomized to receive thalidomide at 1 of 2 doses for 12 weeks initially, with response assessed at weeks 2, 4, 8, and 12. Patients failing the low dose will be eligible to increase the dose to the higher dose. Treatment may continue indefinitely. After 12 weeks, patients continuing treatment are evaluated every 2 months for up to 6 additional months, then every 6 months thereafter.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

HIV Infections

Intervention

Thalidomide

Location

Celgene Corp
Warren
New Jersey
United States
07059

Status

Completed

Source

NIH AIDS Clinical Trials Information Service

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:17-0400

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PubMed Articles [3363 Associated PubMed Articles listed on BioPortfolio]

A validated LC-MS/MS method for the simultaneous determination of thalidomide and its two metabolites in human plasma: Application to a pharmacokinetic assay.

An accurate and sensitive LC-MS/MS method for determining thalidomide, 5-hydroxy thalidomide and 5'-hydroxy thalidomide in human plasma was developed and validated using umbelliferone as an internal s...

Middle-aged individuals with thalidomide embryopathy have undergone few surgical limb procedures and demonstrate a high degree of physical independence.

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Thalidomide induces apoptosis during early mesodermal differentiation of human induced pluripotent stem cells.

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Thalidomide Induces Haematologic Responses in Patients with β-Thalassaemia.

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Thalidomide alleviates postoperative pain and spatial memory deficit in aged rats.

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Medical and Biotech [MESH] Definitions

A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppresive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.

Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.

Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)

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Pathogenic infections of the brain, spinal cord, and meninges. DNA VIRUS INFECTIONS; RNA VIRUS INFECTIONS; BACTERIAL INFECTIONS; MYCOPLASMA INFECTIONS; SPIROCHAETALES INFECTIONS; fungal infections; PROTOZOAN INFECTIONS; HELMINTHIASIS; and PRION DISEASES may involve the central nervous system as a primary or secondary process.

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Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...


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