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.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Lamivudine  Drug: Zidovudine  Drug: Zalcitabine	Phase III

Further Study Details: 

Expected Total Enrollment:  325

Patients are randomized to one of three treatment arms: low-dose 3TC plus AZT, high-dose 3TC plus AZT, or ddC plus AZT. Treatment continues for 32 weeks, with possible extension to 52 weeks. 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• HIV positivity.
• CD4 count 100-300 cells/mm3.
• Prior AZT therapy for 24 or more weeks and currently on AZT.

Exclusion Criteria

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.

California
      ViRx Inc, San Francisco,  California,  94103,  United States
      Combat Group, Los Angeles,  California,  90028,  United States
      San Diego Community Research Group, San Diego,  California,  92104,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
Illinois
      Chicago Ctr for Clinical Research, Chicago,  Illinois,  60607,  United States
Louisiana
      Louisiana Cardiovascular Research Ctr, New Orleans,  Louisiana,  70119,  United States
Massachusetts
      Boston City Hosp / FGH-1, Boston,  Massachusetts,  02118,  United States
New York
      Saint Luke's - Roosevelt Hosp Ctr, New York,  New York,  10019,  United States
      Nassau County Med Ctr, East Meadow,  New York,  11554,  United States
North Carolina
      Nalle Clinic, Charlotte,  North Carolina,  28207,  United States
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  97210,  United States
Pennsylvania
      Milton S Hershey Med Ctr, Hershey,  Pennsylvania,  17033,  United States
Texas
      Univ of Texas Southwestern Med Ctr of Dallas, Dallas,  Texas,  75235,  United States
      Houston Clinical Research Network, Houston,  Texas,  77006,  United States
      Nicholaos Bellos, Dallas,  Texas,  75246,  United States
      Central Texas Med Foundation, Austin,  Texas,  78751,  United States
Wisconsin
      Wisconsin Community - Based Research Consortium, Milwaukee,  Wisconsin,  53202,  United States
Canada, Ontario
      Ottawa General Hospital, Ottawa,  Ontario,  Canada
      Toronto Hosp, Toronto,  Ontario,  Canada
Canada, Quebec
      Montreal Gen Hosp, Montreal,  Quebec,  Canada
Puerto Rico
      Hosp Regional de Ponce - Area Vieja, Ponce,  00731,  Puerto Rico

Study ID Numbers:  129C; NUCA 3002
Record last reviewed:  May 1994
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002436
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08