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.

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

Further Study Details: 

Expected Total Enrollment:  320

Patients are randomized to one of four treatment arms: 3TC alone, AZT alone, low-dose 3TC plus AZT, or high-dose 3TC plus AZT. Patients receive treatment 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:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must have:

• HIV positivity.
• CD4 count 200-500 cells/mm3.
• AZT naive status (<= 4 weeks of prior AZT).

Exclusion Criteria

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.

California
      Combat Group, Los Angeles,  California,  90028,  United States
      Pacific Oaks Med Group, Sherman Oaks,  California,  91403,  United States
      Harbor - UCLA Med Ctr, Torrance,  California,  90509,  United States
      San Diego Community Research Group, San Diego,  California,  92104,  United States
Florida
      Infectious Disease Research Institute Inc, Tampa,  Florida,  33614,  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
      CRI of New England, Brookline,  Massachusetts,  02445,  United States
New York
      Saint Luke's - Roosevelt Hosp Ctr, New York,  New York,  10019,  United States
North Carolina
      Univ of North Carolina School of Medicine, Chapel Hill,  North Carolina,  275997215,  United States
Ohio
      Med College of Ohio, Toledo,  Ohio,  43699,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  97210,  United States
Rhode Island
      Mem Hosp of Rhode Island, Pawtucket,  Rhode Island,  02860,  United States
Texas
      Nicholaos Bellos, Dallas,  Texas,  75246,  United States
      Central Texas Med Foundation, Austin,  Texas,  78751,  United States
Virginia
      Richmond AIDS Consortium, Richmond,  Virginia,  23219,  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
      Advance Community Health Services Inc, Santurce,  00908,  Puerto Rico

Study ID Numbers:  129B; NUCA 3001
Record last reviewed:  May 1994
Last Updated:  April 28, 2003
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002320
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08