A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
A Randomized, Double-Blind Multicenter Trial to Compare the Safety and Efficacy of Lamivudine (3TC; GR109714X) Monotherapy Versus Zidovudine (AZT) Monotherapy Versus 3TC Administered With AZT in the Treatment of HIV-1 Infected Patients Who Are AZT Naive (< 4 Weeks) With CD4 Cell Counts of 200-500 Cells/mm3
2 other identifiers
interventional
320
3 countries
22
Brief Summary
To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients. PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedDecember 12, 2005
May 1, 1994
November 2, 1999
December 8, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- HIV positivity.
- CD4 count 200-500 cells/mm3.
- AZT naive status (\<= 4 weeks of prior AZT).
You may not qualify if:
- Patients with the following prior condition are excluded:
- History of intolerance to AZT.
- Prior Medication:
- Excluded:
- More than 4 weeks of prior AZT.
- Any prior antiretroviral treatment other than AZT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (22)
Combat Group
Los Angeles, California, 90028, United States
San Diego Community Research Group
San Diego, California, 92104, United States
Pacific Oaks Med Group
Sherman Oaks, California, 91403, United States
Harbor - UCLA Med Ctr
Torrance, California, 90509, United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60607, United States
Louisiana Cardiovascular Research Ctr
New Orleans, Louisiana, 70119, United States
CRI of New England
Brookline, Massachusetts, 02445, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019, United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215, United States
Med College of Ohio
Toledo, Ohio, 43699, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Mem Hosp of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Central Texas Med Foundation
Austin, Texas, 78751, United States
Nicholaos Bellos
Dallas, Texas, 75246, United States
Richmond AIDS Consortium
Richmond, Virginia, 23219, United States
Wisconsin Community - Based Research Consortium
Milwaukee, Wisconsin, 53202, 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, 00908, Puerto Rico
Related Publications (2)
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.
PMID: 9030391BACKGROUNDKuritzkes 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.
PMID: 8853730BACKGROUND