A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
NCT ID: NCT00002320
Last Updated: 2005-12-12
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
320 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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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Lamivudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
* HIV positivity.
* CD4 count 200-500 cells/mm3.
* AZT naive status (\<= 4 weeks of prior AZT).
Exclusion Criteria
History of intolerance to AZT.
Prior Medication:
Excluded:
* More than 4 weeks of prior AZT.
* Any prior antiretroviral treatment other than AZT.
12 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
Pacific Oaks Med Group
Sherman Oaks, California, United States
Harbor - UCLA Med Ctr
Torrance, California, United States
Infectious Disease Research Institute Inc
Tampa, Florida, 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
CRI of New England
Brookline, Massachusetts, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Med College of Ohio
Toledo, Ohio, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, United States
Central Texas Med Foundation
Austin, Texas, United States
Nicholaos Bellos
Dallas, Texas, United States
Richmond AIDS Consortium
Richmond, Virginia, 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
Advance Community Health Services Inc
Santurce, , Puerto Rico
Countries
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References
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Eron JJ Jr. The treatment of antiretroviral-naive subjects with the 3TC/zidovudine combination: a review of North American (NUCA 3001) and European (NUCB 3001) trials. AIDS. 1996 Dec;10 Suppl 5:S11-9. doi: 10.1097/00002030-199612005-00003.
Kuritzkes DR, Quinn JB, Benoit SL, Shugarts DL, Griffin A, Bakhtiari M, Poticha D, Eron JJ, Fallon MA, Rubin M. Drug resistance and virologic response in NUCA 3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients. AIDS. 1996 Aug;10(9):975-81. doi: 10.1097/00002030-199610090-00007.
Other Identifiers
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NUCA 3001
Identifier Type: -
Identifier Source: secondary_id
129B
Identifier Type: -
Identifier Source: org_study_id