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15801. A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis

Posted: June 24, 2005 Last Verified: December 1998 Keywords provided by NIH AIDS Clinical Trials Information Service: AIDS-Related Opportunistic Infections Antiviral Agents Drug Administration Schedule Cytomegalovirus Retinitis fomivirsen Vitreous Body Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted (...) Clinical Trials Information Service Study Details Study Description Go to Brief Summary: The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis Condition or disease Intervention/treatment Phase Cytomegalovirus Retinitis HIV Infections Drug: Fomivirsen sodium Not Applicable Detailed Description: This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules

1999 Clinical Trials

15802. Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

Study Description Go to Brief Summary: The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir. Condition or disease Intervention/treatment Phase Herpes Simplex HIV Infections Drug: Cidofovir Not Applicable Detailed Description: Patients receive open-label treatment with cidofovir gel. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Masking (...) HSV infection confirmed by culture of current outbreak. Current HSV outbreak that is unresponsive to >= 10-day course of acyclovir at 1-4 gm/day po or 15 mg/kg/day IV or in vitro resistance of HSV isolate to acyclovir demonstrated within 60 days of study. Signed, informed consent from parent or legal guardian for patients less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Evidence of cervical intraepithelial

1999 Clinical Trials

15803. A Study of Foscarnet in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS Who Have Not Had Success With Ganciclovir

provided by NIH AIDS Clinical Trials Information Service: Retinitis AIDS-Related Opportunistic Infections Ganciclovir Foscarnet Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents Additional relevant MeSH terms: Layout table for MeSH terms Infection HIV Infections Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency (...) previously suffered severe dose-limiting ganciclovir-related myelosuppression, who are ineligible for ganciclovir treatment due to myelosuppression or who have clearly failed to have a therapeutic response to ganciclovir therapy. To assess the duration of clinical response. To evaluate the effect on quantitative CMV cultures of blood and urine. To determine the effect on recovery of HIV p24 antigen capture direct from plasma. Condition or disease Intervention/treatment Phase Cytomegalovirus Retinitis HIV

1999 Clinical Trials

15804. A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients With AIDS

Information Go to Layout table for additonal information ClinicalTrials.gov Identifier: Other Study ID Numbers: 038B JRD 64,433/1102 First Posted: August 31, 2001 Last Update Posted: June 24, 2005 Last Verified: July 1990 Keywords provided by NIH AIDS Clinical Trials Information Service: AIDS-Related Opportunistic Infections Cryptosporidiosis Diarrhea diclazuril Coccidiostats Acquired Immunodeficiency Syndrome Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Cryptosporidiosis (...) /treatment Phase Cryptosporidiosis HIV Infections Drug: Diclazuril Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Primary Purpose: Treatment Official Title: 28 Day Protocol for the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433) Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go

1999 Clinical Trials

15805. A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS

Clinical Trials Information Service: AIDS-Related Opportunistic Infections Ganciclovir Cytomegalovirus Infections Colitis Acquired Immunodeficiency Syndrome Additional relevant MeSH terms: Layout table for MeSH terms Infection HIV Infections Colitis Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Gastroenteritis (...) 24, 2005 Sponsor: Hoffmann-La Roche Information provided by: NIH AIDS Clinical Trials Information Service Study Details Study Description Go to Brief Summary: To attempt to demonstrate the efficacy of ganciclovir (DHPG) treatment of cytomegalovirus (CMV) colitis in AIDS patients by evaluating both clinical and virologic parameters. To determine acceptability and the safety profile of a 2-week course of intravenous (IV) DHPG therapy. Condition or disease Intervention/treatment Phase Colitis HIV

1999 Clinical Trials

15806. A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers

. The parameters to be studied will include: The course of physiological responses to vaccination, including (a) lesion development, progression, and resolution; (b) physiological changes such as temperature, malaise, itching at the site, etc. and (c) any observable AE. The appearance, identity, quantity, and duration of humoral antibodies against HIV and vaccinia virus. The appearance, identity, quantity, and duration of cell-mediated immunity against HIV and vaccinia virus. The adequacy of a procedure using (...) listed under Inclusion Criteria. Development of active eczema or other skin condition which would increase the risk of secondary vaccinia lesions. Appearance of serologic or clinical evidence of HIV infection prior to vaccination. Current evidence of clinically active viral infections such as Mononucleosis, Epstein-Barr Virus, or cytomegalovirus which may affect immunocompetence. Active and overt parasitic, mycobacterial, or pyogenic infections that affect tests designated in Inclusion Criteria

1999 Clinical Trials

15807. A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.

ClinicalTrials.gov Identifier: Other Study ID Numbers: 088D 4152A-PRT005 First Posted: August 31, 2001 Last Update Posted: June 24, 2005 Last Verified: April 1996 Keywords provided by NIH AIDS Clinical Trials Information Service: Neoplasms Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antineoplastic Agents tecogalan Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually (...) Sponsor: Daiichi Pharmaceuticals Information provided by: NIH AIDS Clinical Trials Information Service Study Details Study Description Go to Brief Summary: To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules. Condition or disease Intervention/treatment Phase Sarcoma, Kaposi HIV Infections Drug: Tecogalan sodium Phase 1 Detailed Description: Patients receive intravenous DS-4152 by infusion twice

1999 Clinical Trials

15808. A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4

tecogalan Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue (...) Information provided by: NIH AIDS Clinical Trials Information Service Study Details Study Description Go to Brief Summary: To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules. Condition or disease Intervention/treatment Phase Sarcoma, Kaposi HIV Infections Drug: Tecogalan sodium Phase 1 Detailed Description: Patients receive intravenous DS-4152 by infusion weekly for 4 weeks, followed by 2 weeks

1999 Clinical Trials

15809. A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Every 21 Days

Information provided by: NIH AIDS Clinical Trials Information Service Study Details Study Description Go to Brief Summary: To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules. Condition or disease Intervention/treatment Phase Sarcoma, Kaposi HIV Infections Drug: Tecogalan sodium Phase 1 Detailed Description: Patients receive intravenous DS-4152 by infusion once every 21 days; courses may repeat (...) :A628 Layout table for additonal information ClinicalTrials.gov Identifier: Other Study ID Numbers: 088A 4152A-PRT001 First Posted: August 31, 2001 Last Update Posted: June 24, 2005 Last Verified: April 1996 Keywords provided by NIH AIDS Clinical Trials Information Service: Neoplasms Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antineoplastic Agents tecogalan Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae

1999 Clinical Trials

15810. A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis

Information Go to Publications: Layout table for additonal information ClinicalTrials.gov Identifier: Other Study ID Numbers: 037B GANS2304 First Posted: August 31, 2001 Last Update Posted: June 24, 2005 Last Verified: July 1997 Keywords provided by NIH AIDS Clinical Trials Information Service: Retinitis Ganciclovir Administration, Oral Acquired Immunodeficiency Syndrome Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Retinitis Cytomegalovirus Retinitis Lentivirus Infections (...) in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy. Condition or disease Intervention/treatment Phase Cytomegalovirus Retinitis HIV Infections Drug: Ganciclovir Not Applicable

1999 Clinical Trials

15811. A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS

Numbers: 048E CS 087287-000 First Posted: August 31, 2001 Last Update Posted: June 24, 2005 Last Verified: June 1997 Keywords provided by NIH AIDS Clinical Trials Information Service: Rifabutin Mycobacterium avium-intracellulare Infection Drug Therapy, Combination Ethambutol Acquired Immunodeficiency Syndrome Additional relevant MeSH terms: Layout table for MeSH terms Infection Communicable Diseases HIV Infections Bacteremia Mycobacterium Infections Mycobacterium avium-intracellulare Infection (...) or delaying the incidence of MAC bacteremia in this patient population. Condition or disease Intervention/treatment Phase Mycobacterium Avium-Intracellulare Infection HIV Infections Drug: Ethambutol hydrochloride Drug: Rifabutin Phase 4 Detailed Description: Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs. Study Design Go to Layout table

1999 Clinical Trials

15812. A Study of Tecogalan Sodium

Acquired Immunodeficiency Syndrome Antineoplastic Agents tecogalan Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections Neoplasms (...) of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules. Condition or disease Intervention/treatment Phase Sarcoma, Kaposi HIV Infections Drug: Tecogalan sodium Phase 1 Detailed Description: Patients receive intravenous DS-4152 by infusion twice weekly for 21 days, followed by 2 weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma. Study Design Go to Layout table for study

1999 Clinical Trials

15813. A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia

information Study Chair: Feinberg J More Information Go to Layout table for additonal information ClinicalTrials.gov Identifier: Other Study ID Numbers: 132D TMTX 0015 First Posted: August 31, 2001 Last Update Posted: June 24, 2005 Last Verified: July 1993 Keywords provided by NIH AIDS Clinical Trials Information Service: Trimetrexate Pneumonia, Pneumocystis carinii Leucovorin Drug Therapy, Combination Acquired Immunodeficiency Syndrome Additional relevant MeSH terms: Layout table for MeSH terms HIV (...) provided by: NIH AIDS Clinical Trials Information Service Study Details Study Description Go to Brief Summary: To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine). Condition or disease Intervention/treatment Phase Pneumonia, Pneumocystis Carinii HIV

1999 Clinical Trials

15814. A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy

Cytomegalovirus Retinitis HIV Infections Drug: Ganciclovir Not Applicable Detailed Description: Two hundred twenty-five patients with AIDS and CMV retinitis are eligible for enrollment in Groups A, B, and C of the study, provided that each subject has received and tolerated a therapeutic course of intravenous (IV) ganciclovir of at least 4 weeks duration resulting in stable retinitis. An additional 100 subjects who have received and tolerated a course of IV or oral ganciclovir under any clinical trial of oral (...) and Collaborators Hoffmann-La Roche More Information Go to Publications: Layout table for additonal information ClinicalTrials.gov Identifier: Other Study ID Numbers: 059C ICM 1774 First Posted: August 31, 2001 Last Update Posted: June 24, 2005 Last Verified: March 1993 Keywords provided by NIH AIDS Clinical Trials Information Service: Retinitis Ganciclovir Cytomegalovirus Infections Administration, Oral Acquired Immunodeficiency Syndrome Additional relevant MeSH terms: Layout table for MeSH terms HIV

1999 Clinical Trials

15815. Antidepressant Treatment of AIDS Related Depression.

: To test the effectiveness treating AIDS related depression with imipramine hydrochloride. Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status. This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride (...) hydrochloride. Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status. This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton

2000 Clinical Trials

15816. Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis

): cytomegalovirus retinitis ophthalmologic disorders rare disease Additional relevant MeSH terms: Layout table for MeSH terms Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Retinitis Cytomegalovirus Retinitis Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae (...) ) Collaborator: Northwestern University Information provided by: Office of Rare Diseases (ORD) Study Details Study Description Go to Brief Summary: OBJECTIVES: I. Evaluate the safety and efficacy of intravenous cidofovir in patients with small peripheral cytomegalovirus retinitis. II. Obtain safety and efficacy data related to different dosages of cidofovir. Condition or disease Intervention/treatment Phase Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Drug: cidofovir Phase 2 Detailed

2000 Clinical Trials

15817. Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

in these patients. III. Determine the antileukemic activity of this regimen in these patients. IV. Monitor the development of human antimouse antibody in these patients on this regimen. OUTLINE: This is a dose escalation study. Patients receive B43-genistein immunoconjugate IV over 1 hour on days 1-3, 8-10, and 15-17. Treatment continues every 3 weeks in the absence of unacceptable toxicity or until disease progression. Cohorts of 3-6 patients receive escalating doses of B43-genistein immunoconjugate until (...) ) OR Immunophenotypically proven B-cell non-Hodgkin's lymphoma Refractory or resistant disease following up to 3 prior courses of combination chemotherapy Relapsed following bone marrow transplantation No CNS disease No AIDS-related or HTLV-1 associated lymphomas NHL must be one of the following types: Small lymphocytic lymphoma (consistent with chronic lymphoblastic leukemia) Follicular small cleaved cell lymphoma Follicular mixed cell lymphoma Follicular large cell lymphoma Diffuse small cleaved cell lymphoma Diffuse

2000 Clinical Trials

15818. Fludarabine Followed by Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia

over 30 minutes 5 days a week. Treatment repeats every 28 days for 4 courses in the absence of disease progression. Patients undergo clinical staging after completion of course 4 of fludarabine followed by 2 months of observation. Patients with stable or responding disease receive alemtuzumab subcutaneously 3 days a week for 6 weeks. Patients undergo clinical staging again after completion of 6 weeks of alemtuzumab followed by 2 more months of observation. Patients are followed every 3 months for 1 (...) diagnosis of CLL. No medical condition requiring chronic use of oral corticosteroids. Age ≥18 years. Performance Status 0 - 2. No HIV disease. Due to alterations in host immunity, patients with HIV may not be enrolled. Non-pregnant and non-nursing. Due to the unknown teratogenic potential of Campath-1H, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control. Initial Required Laboratory Values: Creatinine <1.5 x upper

2000 Clinical Trials

15819. SWOG-9239 Reduction of Immunosuppression Plus Interferon Alfa and Combination Chemotherapy in Treating Patients With Malignant Tumors That Develop After Organ Transplant

. Interferon therapy: Patients receive interferon alfa (IFNA) subcutaneously or intramuscularly on days 1-28 for a maximum of 3 courses. Patients then receive maintenance therapy with IFNA 3 days a week for 4 weeks for up to 6 courses. Chemotherapy (ProMACE-CytaBOM): Immunosuppressive therapy is stopped on days 1-20. Patients receive cyclophosphamide IV, doxorubicin IV, and etoposide IV over 60 minutes on day 1, oral prednisone on days 1-14, and cytarabine IV, bleomycin IV, vincristine IV, and methotrexate (...) IV on day 8. Treatment is repeated every 21 days for up to 6 courses. Patients with positive CSF cytology receive intrathecal methotrexate or cytarabine on days 1, 3, 5, 7, and 14. Some patients may continue this therapy on day 21 , then every 3 weeks for 5 doses, or may receive cranial irradiation. Patients are followed monthly for 1 year, every 2 months for 1 year, every 4 months for 1 year, then every 6 months thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study

1999 Clinical Trials

15820. Suramin in Treating Patients With Refractory or Relapsed Multiple Myeloma or Castleman's Disease

the qualitative, quantitative, and cumulative toxic effects of this regimen in these patients. V. Determine the effect of this regimen on the levels of serum interleukin-6 (IL-6), soluble IL-6 receptor, and soluble gp130 in these patients. OUTLINE: Patients receive suramin on days 1-5, 8, 11, 15, 19, 22, and 29. During course 1, patients also receive suramin on days 36, 43, 50, 57, 64, 71, and 78. Suramin is administered IV over 2 hours on day 1 of course 1 and over 1 hour on all subsequent infusion days (...) . Patients undergo rest for at least 12 weeks between each course. Patients with responding disease after completion of course 2 may receive additional courses in the absence of unacceptable toxicity. Patients are followed weekly for 1 month, every 2 weeks for 1 month, at 3 months, and then monthly thereafter if indicated. PROJECTED ACCRUAL: A total of 20-40 patients with multiple myeloma will be accrued for this study within 10-20 months. A total of 20-40 patients with Castleman's disease

1999 Clinical Trials

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