The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT
A Randomized Lamivudine (3TC)/Dideoxycytidine (ddC) Double-Blind Multicenter Trial (With Open-Label AZT) to Evaluate the Safety and Efficacy of Low Dose 3TC Administered Concurrently With AZT Versus High Dose 3TC Administered Concurrently With AZT Versus ddC Administered Concurrently With AZT in the Treatment of HIV-1 Infected, AZT-Experienced (>= 24 Weeks) Patients With CD4 Counts of 100-300 Cells/mm3
2 other identifiers
interventional
325
3 countries
22
Brief Summary
To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT. 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
CompletedJune 24, 2005
May 1, 1994
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- HIV positivity.
- CD4 count 100-300 cells/mm3.
- Prior AZT therapy for 24 or more weeks and currently on AZT.
You may not qualify if:
- Patients with the following prior conditions are excluded:
- 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.
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
ViRx Inc
San Francisco, California, 94103, 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
Boston City Hosp / FGH-1
Boston, Massachusetts, 02118, United States
Nassau County Med Ctr
East Meadow, New York, 11554, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019, United States
Nalle Clinic
Charlotte, North Carolina, 28207, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 17033, United States
Central Texas Med Foundation
Austin, Texas, 78751, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Nicholaos Bellos
Dallas, Texas, 75246, United States
Houston Clinical Research Network
Houston, Texas, 77006, 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
Hosp Regional de Ponce - Area Vieja
Ponce, 00731, Puerto Rico