Clinical trial NCT00002320: A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 320
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Combat Group
state: California
city: San Diego
country: United States
facility: San Diego Community Research Group
state: California
city: Sherman Oaks
country: United States
facility: Pacific Oaks Med Group
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Med Ctr
state: California
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Chicago Ctr for Clinical Research
state: Illinois
city: New Orleans
country: United States
facility: Louisiana Cardiovascular Research Ctr
state: Louisiana
city: Brookline
country: United States
facility: CRI of New England
state: Massachusetts
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina School of Medicine
state: North Carolina
city: Toledo
country: United States
facility: Med College of Ohio
state: Ohio
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
city: Pawtucket
country: United States
facility: Mem Hosp of Rhode Island
state: Rhode Island
city: Austin
country: United States
facility: Central Texas Med Foundation
state: Texas
city: Dallas
country: United States
facility: Nicholaos Bellos
state: Texas
city: Richmond
country: United States
facility: Richmond AIDS Consortium
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Community - Based Research Consortium
state: Wisconsin
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Hosp
state: Ontario
city: Montreal
country: Canada
facility: Montreal Gen Hosp
state: Quebec
city: Santurce
country: Puerto Rico
facility: Advance Community Health Services Inc
Study officials:
References:
citation: 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.
citation: 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.