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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR SOMA COMPOUND

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Clinical Trials for Soma Compound

Trial ID Title Status Sponsor Phase Summary
NCT00000628 A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661. L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
NCT00000628 A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine Completed Merck Sharp & Dohme Corp. Phase 1 Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661. L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
NCT00000675 A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex Completed Genentech, Inc. Phase 1 To study the safety and pharmacokinetics (blood levels) of recombinant human CD4 immunoglobulin (rCd4-IgG) in patients with AIDS or AIDS related complex (ARC) who have failed or declined therapy with zidovudine (AZT). An additional goal of the study is to obtain a preliminary indication of the antiviral effects of Cd4-IgG in patients with AIDS or ARC. Other approaches in addition to existing treatment of HIV infection need to be evaluated. One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the budding of virus from the membrane of the infected cell. In addition, blocking the attachment of HIV to its cellular receptor may offer another point of attack. HIV binds to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus (gp120) is capable of high affinity binding to CD4. Any agent that prevents the attachment of gp120 to the CD4 receptor should be able to block virus transmission and spread. Recently, scientists have succeeded in producing highly purified recombinant soluble human CD4. Recombinant CD4 is capable of binding to HIV envelope protein (gp120) and inhibiting HIV infectivity in test tube studies. Potential therapeutic benefit in patients with HIV infection could be derived from either or both of these biologic effects. In order to extend the length of time that rCD4 stays in the body, the compound has been modified by combining it with a human immunoglobulin of the IgG1 class (IgG).
NCT00000675 A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 To study the safety and pharmacokinetics (blood levels) of recombinant human CD4 immunoglobulin (rCd4-IgG) in patients with AIDS or AIDS related complex (ARC) who have failed or declined therapy with zidovudine (AZT). An additional goal of the study is to obtain a preliminary indication of the antiviral effects of Cd4-IgG in patients with AIDS or ARC. Other approaches in addition to existing treatment of HIV infection need to be evaluated. One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the budding of virus from the membrane of the infected cell. In addition, blocking the attachment of HIV to its cellular receptor may offer another point of attack. HIV binds to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus (gp120) is capable of high affinity binding to CD4. Any agent that prevents the attachment of gp120 to the CD4 receptor should be able to block virus transmission and spread. Recently, scientists have succeeded in producing highly purified recombinant soluble human CD4. Recombinant CD4 is capable of binding to HIV envelope protein (gp120) and inhibiting HIV infectivity in test tube studies. Potential therapeutic benefit in patients with HIV infection could be derived from either or both of these biologic effects. In order to extend the length of time that rCD4 stays in the body, the compound has been modified by combining it with a human immunoglobulin of the IgG1 class (IgG).
NCT00000760 A Randomized Study of Activity, Safety, and Tolerance of Oral Ro 24-7429 (Tat Antagonist) in Patients With HIV Infection Completed Hoffmann-La Roche Phase 1 To study the anti-HIV activity of the various doses of Ro 24-7429 monotherapy based on virologic and immunologic endpoints. To study the safety and tolerance of Ro 24-7429. To explore relationships between exposure to Ro 24-7429 and its metabolites and antiviral activity and drug toxicity. To determine a safe, tolerable, and active dose regimen of Ro 24-7429, and to make preliminary observations of Ro 24-7429 in combination with another antiretroviral nucleoside. The HIV genome contains a number of genes that regulate viral replication. Control of the activity of these genes and their encoded proteins represents a potential target for development of new antiretroviral drugs. The tat (transactivator of transcription of HIV) antagonist Ro 24-7429 is the first compound for clinical testing that utilizes this approach for therapy of HIV infection.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Soma Compound

Condition Name

Condition Name for Soma Compound
Intervention Trials
Healthy 66
Schizophrenia 39
HIV Infections 21
Breast Cancer 19
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Condition MeSH

Condition MeSH for Soma Compound
Intervention Trials
Diabetes Mellitus 42
Schizophrenia 40
Disease 34
Diabetes Mellitus, Type 2 31
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Clinical Trial Locations for Soma Compound

Trials by Country

Trials by Country for Soma Compound
Location Trials
Italy 81
Australia 76
France 55
India 53
Netherlands 46
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Trials by US State

Trials by US State for Soma Compound
Location Trials
California 153
New York 122
Texas 117
Florida 111
Maryland 101
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Clinical Trial Progress for Soma Compound

Clinical Trial Phase

Clinical Trial Phase for Soma Compound
Clinical Trial Phase Trials
Phase 4 119
Phase 3 118
Phase 2/Phase 3 42
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Clinical Trial Status

Clinical Trial Status for Soma Compound
Clinical Trial Phase Trials
Completed 666
Recruiting 198
Unknown status 86
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Clinical Trial Sponsors for Soma Compound

Sponsor Name

Sponsor Name for Soma Compound
Sponsor Trials
GlaxoSmithKline 74
Pfizer 59
National Cancer Institute (NCI) 39
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Sponsor Type

Sponsor Type for Soma Compound
Sponsor Trials
Other 1022
Industry 707
NIH 141
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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Citi
UBS
Fish and Richardson
Cerilliant
Express Scripts
Chinese Patent Office
Healthtrust
Fuji

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