Home | All trials

[RDF data]
Trial NCT00000625

Resource URI: http://static.linkedct.org/resource/trials/NCT00000625
PropertyValue
linkedct:brief_title A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/3124>
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/932>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Concurrent Medication: Allowed: - PCP prophylaxis, M. tuberculosis prophylaxis, short courses of acyclovir, chronic suppressive acyclovir, pneumovax or Hib vaccine, antibiotics, rEPO and G-CSF for grade 3 or worse anemia and neutropenia, systemic corticosteroids for < 21 days, regularly prescribed medications, and vitamins or herbal therapies. Patients must have: - HIV infection without AIDS with CD4 200-500 cells/mm3. PER AMENDMENT 4/5/95: - Patients must have remained on ACTG 175 study treatment through 4/30/95 and meet toxicity management criteria for continuing treatment. Subjects taking ACTG 175 crossover treatment are eligible. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: - Current AIDS-related condition other than minimal KS, grade 2 or worse peripheral neuropathy, and malignancy requiring systemic therapy. Concurrent Medication: Excluded: - Other anti-HIV drugs, biologic response modifiers other than rEPO and G-CSF, systemic cytotoxic chemotherapy, chronic systemic corticosteroids, or any drug that affects AZT glucuronidation or clearance. Concurrent Treatment: Excluded: - Radiotherapy other than limited local therapy to skin. Patients with the following prior conditions are excluded: - AIDS-related condition other than minimal KS; intolerance to AZT, ddI, or ddC at study doses; and acute or chronic pancreatitis. Prior Medication: Excluded: - Acute therapy for an infection or other medical illness within the past 14 days. Current alcohol abuse.
linkedct:description Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm. PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 12 Years
linkedct:enrollment 2100 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000625
rdfs:label Trial NCT00000625
linkedct:lastchanged_date August 6, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/105305>
linkedct:location <http://static.linkedct.org/resource/location/146815>
linkedct:location <http://static.linkedct.org/resource/location/146929>
linkedct:location <http://static.linkedct.org/resource/location/146944>
linkedct:location <http://static.linkedct.org/resource/location/147026>
linkedct:location <http://static.linkedct.org/resource/location/147425>
linkedct:location <http://static.linkedct.org/resource/location/147596>
linkedct:location <http://static.linkedct.org/resource/location/147780>
linkedct:location <http://static.linkedct.org/resource/location/147801>
linkedct:location <http://static.linkedct.org/resource/location/147803>
linkedct:location <http://static.linkedct.org/resource/location/148174>
linkedct:location <http://static.linkedct.org/resource/location/148178>
linkedct:location <http://static.linkedct.org/resource/location/149137>
linkedct:location <http://static.linkedct.org/resource/location/149740>
linkedct:location <http://static.linkedct.org/resource/location/150163>
linkedct:location <http://static.linkedct.org/resource/location/151107>
linkedct:location <http://static.linkedct.org/resource/location/151114>
linkedct:location <http://static.linkedct.org/resource/location/152638>
linkedct:location <http://static.linkedct.org/resource/location/152713>
linkedct:location <http://static.linkedct.org/resource/location/152982>
linkedct:location <http://static.linkedct.org/resource/location/153195>
linkedct:location <http://static.linkedct.org/resource/location/153261>
linkedct:location <http://static.linkedct.org/resource/location/153326>
linkedct:location <http://static.linkedct.org/resource/location/153656>
linkedct:location <http://static.linkedct.org/resource/location/153759>
linkedct:location <http://static.linkedct.org/resource/location/153760>
linkedct:location <http://static.linkedct.org/resource/location/153802>
linkedct:location <http://static.linkedct.org/resource/location/154431>
linkedct:location <http://static.linkedct.org/resource/location/154456>
linkedct:location <http://static.linkedct.org/resource/location/154457>
linkedct:location <http://static.linkedct.org/resource/location/154471>
linkedct:location <http://static.linkedct.org/resource/location/154495>
linkedct:location <http://static.linkedct.org/resource/location/154546>
linkedct:location <http://static.linkedct.org/resource/location/154547>
linkedct:location <http://static.linkedct.org/resource/location/154562>
linkedct:location <http://static.linkedct.org/resource/location/154595>
linkedct:location <http://static.linkedct.org/resource/location/155019>
linkedct:location <http://static.linkedct.org/resource/location/155251>
linkedct:location <http://static.linkedct.org/resource/location/155444>
linkedct:location <http://static.linkedct.org/resource/location/155582>
linkedct:location <http://static.linkedct.org/resource/location/155963>
linkedct:location <http://static.linkedct.org/resource/location/156520>
linkedct:location <http://static.linkedct.org/resource/location/156869>
linkedct:location <http://static.linkedct.org/resource/location/157323>
linkedct:location <http://static.linkedct.org/resource/location/158057>
linkedct:location <http://static.linkedct.org/resource/location/158840>
linkedct:location <http://static.linkedct.org/resource/location/158843>
linkedct:location <http://static.linkedct.org/resource/location/160165>
linkedct:location <http://static.linkedct.org/resource/location/160553>
linkedct:location <http://static.linkedct.org/resource/location/161468>
linkedct:location <http://static.linkedct.org/resource/location/161537>
linkedct:location <http://static.linkedct.org/resource/location/161766>
linkedct:location <http://static.linkedct.org/resource/location/161768>
linkedct:location <http://static.linkedct.org/resource/location/161829>
linkedct:location <http://static.linkedct.org/resource/location/163107>
linkedct:location <http://static.linkedct.org/resource/location/163631>
linkedct:location <http://static.linkedct.org/resource/location/166219>
linkedct:location <http://static.linkedct.org/resource/location/166682>
linkedct:location <http://static.linkedct.org/resource/location/166684>
linkedct:location <http://static.linkedct.org/resource/location/166831>
linkedct:location <http://static.linkedct.org/resource/location/167038>
linkedct:location <http://static.linkedct.org/resource/location/167089>
linkedct:location <http://static.linkedct.org/resource/location/167519>
linkedct:location <http://static.linkedct.org/resource/location/168367>
linkedct:location <http://static.linkedct.org/resource/location/168867>
linkedct:location <http://static.linkedct.org/resource/location/170798>
linkedct:location <http://static.linkedct.org/resource/location/173756>
linkedct:location <http://static.linkedct.org/resource/location/177831>
linkedct:location <http://static.linkedct.org/resource/location/179656>
linkedct:location <http://static.linkedct.org/resource/location/180769>
linkedct:location <http://static.linkedct.org/resource/location/181782>
linkedct:location <http://static.linkedct.org/resource/location/182105>
linkedct:location <http://static.linkedct.org/resource/location/182262>
linkedct:location <http://static.linkedct.org/resource/location/182402>
linkedct:location <http://static.linkedct.org/resource/location/184220>
linkedct:location <http://static.linkedct.org/resource/location/184724>
linkedct:location <http://static.linkedct.org/resource/location/184829>
linkedct:location <http://static.linkedct.org/resource/location/184968>
linkedct:location <http://static.linkedct.org/resource/location/186734>
linkedct:location <http://static.linkedct.org/resource/location/187440>
linkedct:location <http://static.linkedct.org/resource/location/188256>
linkedct:location <http://static.linkedct.org/resource/location/188286>
linkedct:location <http://static.linkedct.org/resource/location/188687>
linkedct:location <http://static.linkedct.org/resource/location/188688>
linkedct:location <http://static.linkedct.org/resource/location/188689>
linkedct:location <http://static.linkedct.org/resource/location/189359>
linkedct:location <http://static.linkedct.org/resource/location/189600>
linkedct:location <http://static.linkedct.org/resource/location/190334>
linkedct:location <http://static.linkedct.org/resource/location/192432>
linkedct:location <http://static.linkedct.org/resource/location/192501>
linkedct:location <http://static.linkedct.org/resource/location/192654>
linkedct:location <http://static.linkedct.org/resource/location/192729>
linkedct:location <http://static.linkedct.org/resource/location/194611>
linkedct:location <http://static.linkedct.org/resource/location/196910>
linkedct:location <http://static.linkedct.org/resource/location/196911>
linkedct:location <http://static.linkedct.org/resource/location/196912>
linkedct:location <http://static.linkedct.org/resource/location/197263>
linkedct:location <http://static.linkedct.org/resource/location/197342>
linkedct:location <http://static.linkedct.org/resource/location/197349>
linkedct:location <http://static.linkedct.org/resource/location/197412>
linkedct:location <http://static.linkedct.org/resource/location/200322>
linkedct:location <http://static.linkedct.org/resource/location/202210>
linkedct:location <http://static.linkedct.org/resource/location/203039>
linkedct:location <http://static.linkedct.org/resource/location/205878>
linkedct:location <http://static.linkedct.org/resource/location/205879>
linkedct:location <http://static.linkedct.org/resource/location/205885>
linkedct:location <http://static.linkedct.org/resource/location/205889>
linkedct:location <http://static.linkedct.org/resource/location/209908>
linkedct:location <http://static.linkedct.org/resource/location/209958>
linkedct:location <http://static.linkedct.org/resource/location/209960>
linkedct:location <http://static.linkedct.org/resource/location/210213>
linkedct:location <http://static.linkedct.org/resource/location/210748>
linkedct:location <http://static.linkedct.org/resource/location/211369>
linkedct:location <http://static.linkedct.org/resource/location/212008>
linkedct:location <http://static.linkedct.org/resource/location/212204>
linkedct:location <http://static.linkedct.org/resource/location/212211>
linkedct:location <http://static.linkedct.org/resource/location/213279>
linkedct:location <http://static.linkedct.org/resource/location/213506>
linkedct:location <http://static.linkedct.org/resource/location/216071>
linkedct:location <http://static.linkedct.org/resource/location/216072>
linkedct:location <http://static.linkedct.org/resource/location/216187>
linkedct:location <http://static.linkedct.org/resource/location/216906>
linkedct:location <http://static.linkedct.org/resource/location/216907>
linkedct:location <http://static.linkedct.org/resource/location/217318>
linkedct:location <http://static.linkedct.org/resource/location/217741>
linkedct:location <http://static.linkedct.org/resource/location/218526>
linkedct:location <http://static.linkedct.org/resource/location/218711>
linkedct:location <http://static.linkedct.org/resource/location/220319>
linkedct:nct_id NCT00000625
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
linkedct:org_study_id ACTG 175
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/21488>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/32281>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000625>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/12042>
linkedct:reference <http://static.linkedct.org/resource/reference/4763>
linkedct:reference <http://static.linkedct.org/resource/reference/49778>
linkedct:reference <http://static.linkedct.org/resource/reference/50592>
linkedct:reference <http://static.linkedct.org/resource/reference/50593>
linkedct:reference <http://static.linkedct.org/resource/reference/53946>
linkedct:reference <http://static.linkedct.org/resource/reference/53947>
linkedct:reference <http://static.linkedct.org/resource/reference/55687>
linkedct:reference <http://static.linkedct.org/resource/reference/55744>
linkedct:reference <http://static.linkedct.org/resource/reference/8247>
linkedct:reference <http://static.linkedct.org/resource/reference/9188>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Double-Blind, Safety Study
linkedct:study_type Interventional
linkedct:summary To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
rdf:type linkedct:trials
linkedct:verification_date January 2003