The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT
NCT ID: NCT00002436
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
325 participants
INTERVENTIONAL
Brief Summary
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PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.
Detailed Description
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PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.
Conditions
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Study Design
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TREATMENT
Interventions
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Lamivudine
Zidovudine
Zalcitabine
Eligibility Criteria
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Inclusion Criteria
* HIV positivity.
* CD4 count 100-300 cells/mm3.
* Prior AZT therapy for 24 or more weeks and currently on AZT.
Exclusion Criteria
* History of intolerance to AZT.
* History of grade 2 or worse peripheral neuropathy.
Prior Medication:
Excluded:
* Any prior antiretroviral therapy other than AZT.
Required:
* Concomitant AZT therapy.
Required:
* At least 24 weeks of prior AZT.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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Combat Group
Los Angeles, California, United States
San Diego Community Research Group
San Diego, California, United States
ViRx Inc
San Francisco, California, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Chicago Ctr for Clinical Research
Chicago, Illinois, United States
Louisiana Cardiovascular Research Ctr
New Orleans, Louisiana, United States
Boston City Hosp / FGH-1
Boston, Massachusetts, United States
Nassau County Med Ctr
East Meadow, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Nalle Clinic
Charlotte, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States
Central Texas Med Foundation
Austin, Texas, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Nicholaos Bellos
Dallas, Texas, United States
Houston Clinical Research Network
Houston, Texas, United States
Wisconsin Community - Based Research Consortium
Milwaukee, Wisconsin, United States
Ottawa General Hospital
Ottawa, Ontario, Canada
Toronto Hosp
Toronto, Ontario, Canada
Montreal Gen Hosp
Montreal, Quebec, Canada
Hosp Regional de Ponce - Area Vieja
Ponce, , Puerto Rico
Countries
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Other Identifiers
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NUCA 3002
Identifier Type: -
Identifier Source: secondary_id
129C
Identifier Type: -
Identifier Source: org_study_id