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The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zidovudine
Zalcitabine
Didanosine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Patients with PCP may be randomized to study medication after contacting the sponsor and following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 C for at least 48 hours, p02 (on room air) > or = 60 mm and an A/A gradient < or = 30 mm. Prophylaxis for PCP. Patients must have the following: HIV-1 seropositive by any federally licensed ELISA. Willingness to give informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Any immediately life-threatening infection or medical condition present at time of study entry. Any active opportunistic infection requiring chronic therapy with any of the agents listed in the exclusion concurrent medication section. Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix. Kaposi's sarcoma with visceral involvement or requiring systemic cytotoxic chemotherapy. AIDS dementia complex, > or = Stage 2. History of zidovudine induced toxicity. Prior history of acute pancreatitis during the past two years or chronic pancreatitis. Grade 2 neuropathy. Intractable diarrhea. History of seizures within the past six months or current requirement of anticonvulsants. Past or current heart disease. Fever > 39 C at entry. Concurrent Medication: Current requirement of anticonvulsants. Excluded: It is intended that patients developing new opportunistic infections during the course of the study will continue study participation, unless required therapy is associated with significant neurologic or hematologic toxicities, in which case the study medication may be temporarily discontinued. Ganciclovir. Chloramphenicol. Cisplatinum. Iodoquinol. Systemic Pentamidine. Disulfiram. Ethionamide. Glutethimide. Gold. Hydralazine. Metronidazole. Sodium Cyanate. Thalidomide. Vincristine. Allopurinol. Probenecid. Concurrent Treatment: Excluded: Radiation therapy. (with the exception of electron beam therapy to an area of < 100cm/m2.) Patients with the following are excluded: Any immediately life-threatening infection or medical condition present at time of study entry. Any active opportunistic infection requiring chronic therapy with any of the agents listed in the exclusion concurrent medication section. Active alcohol or drug abuse, sufficient in the investigator's opinion to prevent compliance with study therapy. Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix. Kaposi's syndrome with visceral involvement or requiring systemic cytotoxic chemotherapy. AIDS dementia complex, > or = Stage 2. History of zidovudine induced toxicity. Any experimental therapy within 30 days. Prior history of acute pancreatitis during the past two years or chronic pancreatitis. Grade 2 neuropathy. Intractable diarrhea. History of seizures within the past six months or current requirement of anticonvulsants. History of past or current heart disease. Fever > 39 C at entry. Prior Medication: Excluded: Any anti-HIV therapy (other than zidovudine), biologic response modifiers, or pharmacologic doses of corticosteroids within eight weeks of entry (except for the management of severe PCP, in which case duration is not to exceed 21 days). Zidovudine therapy for greater than four weeks or prior discontinuation due to drug toxicity. Prior therapy with ddI, ddC, D4T, or interferon. Any experimental therapy within 30 days. Therapy within 30 days with neurotoxic drugs. Prior Treatment: Excluded: Radiation therapy within two weeks of entry or likely to require radiation therapy (with the exception of electron beam therapy to an area of < 100cm/m2). Active alcohol or drug abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy.

Sites / Locations

  • Univ of Colorado Health Sciences Ctr
  • Georgetown Univ Med Ctr / Main Hosp 4
  • Vanderbilt School of Medicine
  • Saint Vincent's Hosp Med Centre
  • San Juan Veterans Administration Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002001
Brief Title
The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease
Official Title
The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 1991
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
To evaluate the virologic effect of combined administration of zidovudine and ddI or ddC. To evaluate the immunologic effects of zidovudine and ddI or ddC. To evaluate combined administration of zidovudine and ddI or ddC for clinical efficacy. To evaluate the safety and the tolerance of the coadministration of zidovudine and ddI or ddC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Zalcitabine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Patients with PCP may be randomized to study medication after contacting the sponsor and following a minimum 7-day course of therapy resulting in stabilization of their disease. Patients with stabilized disease must have fever < 39 C for at least 48 hours, p02 (on room air) > or = 60 mm and an A/A gradient < or = 30 mm. Prophylaxis for PCP. Patients must have the following: HIV-1 seropositive by any federally licensed ELISA. Willingness to give informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Any immediately life-threatening infection or medical condition present at time of study entry. Any active opportunistic infection requiring chronic therapy with any of the agents listed in the exclusion concurrent medication section. Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix. Kaposi's sarcoma with visceral involvement or requiring systemic cytotoxic chemotherapy. AIDS dementia complex, > or = Stage 2. History of zidovudine induced toxicity. Prior history of acute pancreatitis during the past two years or chronic pancreatitis. Grade 2 neuropathy. Intractable diarrhea. History of seizures within the past six months or current requirement of anticonvulsants. Past or current heart disease. Fever > 39 C at entry. Concurrent Medication: Current requirement of anticonvulsants. Excluded: It is intended that patients developing new opportunistic infections during the course of the study will continue study participation, unless required therapy is associated with significant neurologic or hematologic toxicities, in which case the study medication may be temporarily discontinued. Ganciclovir. Chloramphenicol. Cisplatinum. Iodoquinol. Systemic Pentamidine. Disulfiram. Ethionamide. Glutethimide. Gold. Hydralazine. Metronidazole. Sodium Cyanate. Thalidomide. Vincristine. Allopurinol. Probenecid. Concurrent Treatment: Excluded: Radiation therapy. (with the exception of electron beam therapy to an area of < 100cm/m2.) Patients with the following are excluded: Any immediately life-threatening infection or medical condition present at time of study entry. Any active opportunistic infection requiring chronic therapy with any of the agents listed in the exclusion concurrent medication section. Active alcohol or drug abuse, sufficient in the investigator's opinion to prevent compliance with study therapy. Neoplasms other than basal cell carcinoma or in situ carcinoma of the cervix. Kaposi's syndrome with visceral involvement or requiring systemic cytotoxic chemotherapy. AIDS dementia complex, > or = Stage 2. History of zidovudine induced toxicity. Any experimental therapy within 30 days. Prior history of acute pancreatitis during the past two years or chronic pancreatitis. Grade 2 neuropathy. Intractable diarrhea. History of seizures within the past six months or current requirement of anticonvulsants. History of past or current heart disease. Fever > 39 C at entry. Prior Medication: Excluded: Any anti-HIV therapy (other than zidovudine), biologic response modifiers, or pharmacologic doses of corticosteroids within eight weeks of entry (except for the management of severe PCP, in which case duration is not to exceed 21 days). Zidovudine therapy for greater than four weeks or prior discontinuation due to drug toxicity. Prior therapy with ddI, ddC, D4T, or interferon. Any experimental therapy within 30 days. Therapy within 30 days with neurotoxic drugs. Prior Treatment: Excluded: Radiation therapy within two weeks of entry or likely to require radiation therapy (with the exception of electron beam therapy to an area of < 100cm/m2). Active alcohol or drug abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy.
Facility Information:
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Georgetown Univ Med Ctr / Main Hosp 4
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Vanderbilt School of Medicine
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Saint Vincent's Hosp Med Centre
City
Darlinghurst
Country
Australia
Facility Name
San Juan Veterans Administration Med Ctr
City
San Juan
ZIP/Postal Code
009275800
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
8709213
Citation
Larder BA, Kohli A, Bloor S, Kemp SD, Harrigan PR, Schooley RT, Lange JM, Pennington KN, St Clair MH. Human immunodeficiency virus type 1 drug susceptibility during zidovudine (AZT) monotherapy compared with AZT plus 2',3'-dideoxyinosine or AZT plus 2',3'-dideoxycytidine combination therapy. The protocol 34,225-02 Collaborative Group. J Virol. 1996 Sep;70(9):5922-9. doi: 10.1128/JVI.70.9.5922-5929.1996.
Results Reference
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The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-Dideoxyinosine or 2',3'-Dideoxycytidine in Patients With Human Immunodeficiency Virus Disease

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