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HIV Course

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15761. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Older Patients With Non-Hodgkin's Lymphoma

: Patients receive treatment as in arm I. Patients also receive rituximab IV on days -7,-3, 41, and 83. Patients who achieve complete response (CR) after 4 courses of CHOP and remain in CR after 6 courses of CHOP are further randomized to one of two arms. Arm I (Maintenance therapy): Patients receive rituximab IV weekly for 4 weeks. Courses repeat every 6 months for 2 years in the absence of unacceptable toxicity. Arm II: Patients are observed. Patients who achieve partial response (PR) after 6 courses (...) OR PR after 4 courses and then CR after 6 courses receive 2 additional courses of CHOP therapy. Patients are then also randomized to receive either maintenance therapy or observation as above. Patients with stable disease or disease progression are removed from the study. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 4 years. Study Design Go to Layout

1999 Clinical Trials

15762. Paclitaxel With or Without PSC 833 in Treating Patients With Metastatic Breast Cancer

weeks. In the second arm, PSC 833 is administered PO four times a day for 3 days; paclitaxel is administered by continuous infusion over 3 hours on day 2. Courses repeat every 3 weeks. PROJECTED ACCRUAL: Approximately 70 patients will be accrued per year in this study. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 70 participants Allocation: Randomized Primary Purpose: Treatment Official Title: A Phase II Randomized Study (...) CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 8.0 g/dL Absolute neutrophil count at least 1500/mm3 Hepatic: Total serum bilirubin no greater than 1.5 mg/dL No history of chronic active hepatitis or cirrhosis SGOT and/or SGPT no greater than 2 times the upper limit of normal Renal: Serum creatinine no greater than 2.0 mg/dL Other: Not HIV positive Not pregnant or nursing Effective

1999 Clinical Trials

15763. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer

Drug: carboplatin Drug: etoposide Drug: ifosfamide Drug: paclitaxel Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Phase 2 Detailed Description: OBJECTIVES: Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens with autologous stem cell rescue in patients with relapsed germ cell cancer. Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem cell support followed by paclitaxel (...) , carboplatin and ifosfamide with stem cell support in these patients. OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells cannot be collected. Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and carboplatin (CBDCA) IV over 30 minutes 3 times daily

1999 Clinical Trials

15764. KRN5500 in Treating Patients With Metastatic Solid Tumors

: OBJECTIVES: I. Determine the maximum tolerated dose and toxicities of KRN5500 in patients with solid malignant tumors. II. Characterize the clinical pharmacokinetics of KRN5500 in this patient population. III. Initiate the preliminary evaluation of antitumor activity of KRN5500 in these patients. IV. Determine the recommended Phase II dose of KRN5500. OUTLINE: This is a dose escalation study. Patients receive KRN5500 IV over 1 hour on days 1-3. Courses repeat every 21 days. Patients with stable disease (...) no greater than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of acute myocardial infarction within the past 6 months No clinically significant cardiac arrhythmias No New York Heart Association class III or IV disease Other: HIV negative No GI bleeding or bleeding tendency Not pregnant or nursing Effective contraception required for fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Must have recovered from prior

1999 Clinical Trials

15765. Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Patients With Acute Myelogenous Leukemia

followed by 2 courses of HiDAC in patients who would otherwise receive PBSC transplant, but are unable to do so for logistical or institutional reasons. V. Determine the feasibility of intermittent administration of high dose subcutaneous interleukin-2 (IL-2) in combination with continuous low dose subcutaneous IL-2 in patients recovering from PBSC transplant or intensive consolidation chemotherapy. OUTLINE: This is a dose escalation study of daunorubicin in the induction therapy portion (...) , with a separate dose escalation study of etoposide in the same portion. Patients are treated with three phases of treatment: induction, intensification, and postremission therapy. Induction therapy: Patients receive cytarabine IV as a continuous infusion on days 1-7 plus daunorubicin IV over 30 minutes and etoposide IV over 2 hours on days 1-3 (ADE regimen). Some patients also receive PSC 833 IV as a continuous infusion on days 1-3 (ADEP regimen). This course may be repeated 14 days later. Cohorts of 9

1999 Clinical Trials

15766. Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer

and their disease that might influence the outcome of this therapy. OUTLINE: Patients receive carboplatin and etoposide for 5 days and cyclophosphamide for 2 days prior to ABMT. At day 60 following ABMT, if the patient has a complete response (CR) or partial response (PR) and nonhematologic toxicity is no greater than grade 2, a second ABMT course is given when hematologic parameters and other criteria are acceptable. If there is no CR or PR and/or nonhematologic toxicity exceeds grade 2, a second ABMT (...) % of predicted Other: Not HIV positive No active peptic ulcer No uncontrolled diabetes mellitus No active infection No previous or concomitant malignancy other than curatively treated basal or squamous cell carcinoma of the skin Not HBsAG positive PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior high-dose carboplatin, etoposide, or cyclophosphamide Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Contacts and Locations Go to Information from

1999 Clinical Trials

15767. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin's or Non-Hodgkin's Lymphoma

function after transplantation in these patients. OUTLINE: Patients receive 2 courses of reinduction chemotherapy followed by bone marrow biopsy and aspirate prior to peripheral blood stem cell (PBSC) harvest. If marrow involvement is still present at harvest, then 2 additional courses of induction chemotherapy are given. The PBSC transplantation preparative regimen should begin within 2 weeks of completing reinduction therapy course, consisting of the following: Carmustine IV over 3 hours on days -8 (...) Date : March 2007 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: Reinduction Therapy Two courses of reinduction chemotherapy followed by bone marrow biopsy and aspirate prior to peripheral blood stem cell (PBSC) harvest. If marrow involvement is still present at harvest, then 2 additional courses of induction chemotherapy are given. The PBSC transplantation preparative

1999 Clinical Trials

15768. Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS

Lymphoma Drug: hydroxyurea Phase 2 Detailed Description: OBJECTIVES: I. Estimate the objective response rate of PCNSL in AIDS patients treated with hydroxyurea. II. Investigate whether levels of Epstein-Barr virus (EBV) DNA in the blood or cerebral spinal fluid are correlates of PCNSL disease activity. OUTLINE: This is an open label pilot study. Patients receive oral hydroxyurea tid. A course of hydroxyurea consists of 4 weeks of therapy. On day 28, after the first course of treatment, tumor size (...) Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove

1999 Clinical Trials

15769. Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

bryostatin 1 IV continuously on days 1-3 immediately followed by cladribine IV continuously on days 4-8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR. Cohorts of 3-6 patients receive escalating dose levels of cladribine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity (...) participation No HIV infection No AIDS PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: See Disease Characteristics No concurrent steroids No concurrent hormonal contraceptives Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: No other concurrent therapy Contacts

1999 Clinical Trials

15770. A Treatment Protocol for the Use of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis Carinii Pneumonia and Serious Intolerance to Approved Therapies

Immunodeficiency Syndrome Antiprotozoal Agents AIDS-Related Complex Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections (...) trimetrexate (TMTX) with leucovorin rescue (LCV) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection, and who have demonstrated serious adverse effects from the conventional therapies for PCP. The drugs usually used to treat PCP in AIDS patients (trimethoprim / sulfamethoxazole and pentamidine) have had to be discontinued in many patients because of severe adverse effects. Currently there are no proven alternatives

1999 Clinical Trials

15771. A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems

in the patient's blood. RBV is a new drug capable of inhibiting the growth of the AIDS virus in the laboratory with little effect on normal human cells. In earlier tests of RBV in AIDS patients, the drug was well tolerated and safe, and this favorable result suggested that RBV should be more extensively studied in patients with AIDS and advanced AIDS related complex (ARC). Condition or disease Intervention/treatment Phase HIV Infections Drug: Ribavirin Phase 1 Detailed Description: RBV is a new drug capable (...) : ACTG 034 11010 ( Registry Identifier: DAIDS ES Registry Number ) First Posted: August 31, 2001 Last Update Posted: March 29, 2012 Last Verified: March 2012 Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Ribavirin T-Lymphocytes Acquired Immunodeficiency Syndrome AIDS-Related Complex Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted

1999 Clinical Trials

15772. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia

Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Zidovudine Pentamidine Antimetabolites Molecular Mechanisms (...) provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID) Study Details Study Description Go to Brief Summary: To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with advanced HIV disease and T4 cell count < 200 cells/mm3. To establish the range of pentamidine (PEN) deposition in AIDS patients participating in ACTG 021 and ACTG 081. To identify factors (breathing pattern, pulmonary function) that may be important in affecting

1999 Clinical Trials

15773. A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma

Identifier: Other Study ID Numbers: ACTG 006 10982 ( Registry Identifier: DAIDS ES Registry Number ) First Posted: August 31, 2001 Last Update Posted: March 16, 2012 Last Verified: March 2012 Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Doxorubicin Drug Evaluation Acquired Immunodeficiency Syndrome Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Sarcoma Sarcoma, Kaposi Lentivirus Infections Retroviridae Infections RNA Virus Infections (...) provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID) Study Details Study Description Go to Brief Summary: To study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness and safety of weekly administration of small doses of doxorubicin. Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears

1999 Clinical Trials

15774. A Study of BufferGel in Women

HIV infections worldwide. Currently the condom is the only method available that has been shown to be effective against HIV and other sexually transmitted diseases (STDs). However, women who are at the greatest risk for acquiring HIV are often unable to negotiate condom use. Therefore, it is important that effective female-controlled barrier methods, such as topical microbicides, be made available to women. BufferGel has sufficient buffer capacity to acidify twice its own volume in human semen (...) Institute of Allergy and Infectious Diseases (NIAID): Administration, Topical Mucous Membrane Anti-Infective Agents Cervix Uteri Vagina Vulva Buffers Additional relevant MeSH terms: Layout table for MeSH terms HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

1999 Clinical Trials

15775. Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects

AMENDMENT 12/19/97: To delineate the possible development of cellular resistance to nucleoside analogs and the consequences of switching nucleoside study drugs on intracellular phosphorylation.] To document rates and patterns of adherence over the course of the study, from day of randomization through 48 weeks. [AS PER AMENDMENT 8/24/98: To define long-term durability of the virologic activity of the different treatment regimens, as defined by the proportion of patients with plasma HIV-1 RNA levels (...) : Layout table for MeSH terms HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Zidovudine Stavudine Delavirdine Indinavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV

1999 Clinical Trials

15776. A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir

Therapy, Combination Foscarnet Cytomegalovirus Infections Acquired Immunodeficiency Syndrome 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 Syndromes Immune System Diseases Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA (...) ) infections. G-CSF or GM-CSF for grade 4 neutropenia. Concurrent Treatment: Allowed: Recombinant human erythropoietin. Prior Medication: Required: Completion of 14-day course of intravenous ganciclovir induction therapy (2.5 mg/kg IV q8h or 5 mg/kg q12h for 14 days) or foscarnet induction therapy (60 mg/kg q8h adjusted for renal function for 14 days) within 1 week prior to study entry. Patients who do not initiate the study immediately upon completing ganciclovir induction therapy should receive

1999 Clinical Trials

15777. A Study of Chemotherapy Plus ddI or ddC in the Treatment of AIDS-Related Kaposi's Sarcoma

Didanosine Doxorubicin Drug Evaluation Drug Interactions Drug Therapy, Combination Combined Modality Therapy Acquired Immunodeficiency Syndrome Antineoplastic Agents Antineoplastic Agents, Combined Antiviral Agents Bleomycin 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 (...) cell counts < 200 cells/mm3. Allowed: Chemoprophylaxis for candidiasis, MAC, and herpes simplex. Up to 14-day courses of metronidazole. Recombinant erythropoietin. Granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte colony stimulating factor (G-CSF) for patients with ANC < 1000 cells/mm3. Isoniazid for treatment of tuberculosis, with permission of the protocol chair, when given in conjunction with pyridoxine. Patients must have: HIV infection. Kaposi's sarcoma. For patients

1999 Clinical Trials

15778. Study of Women Who Have AIDS

the effect of pregnancy, age, drug use, and coinfections on HIV progression rate. To document the prevalence, incidence, characteristics, and course of HIV infection and anogenital intraepithelial neoplasia among HIV-positive and HIV-negative women. To study the effect of HIV disease on gynecologic health including infections and reproductive function. Condition or disease HIV Infections Study Design Go to Layout table for study information Study Type : Observational Enrollment : 1250 participants (...) relevant MeSH terms: Layout table for MeSH terms HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

1999 Clinical Trials

15779. A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes

, 2012 Last Verified: March 2012 Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Infusions, Intravenous Ganciclovir Administration, Oral Acquired Immunodeficiency Syndrome Antiviral Agents Cytomegalovirus Retinitis 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 (...) . Condition or disease Intervention/treatment Phase Cytomegalovirus Retinitis HIV Infections Drug: Ganciclovir Phase 1 Detailed Description: A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV

1999 Clinical Trials

15780. Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS

and Infectious Diseases (NIAID): AIDS-Related Opportunistic Infections Ganciclovir Foscarnet Acquired Immunodeficiency Syndrome Antibodies, Monoclonal Cytomegalovirus Retinitis 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 Diseases Immunologic Deficiency Syndromes Immune System Diseases Retinal Diseases Eye (...) Institute of Allergy and Infectious Diseases (NIAID) Collaborator: Facet Biotech Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID) Study Details Study Description Go to Brief Summary: To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL

1999 Clinical Trials

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