A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past

Condition(s) targeted: HIV Infections

Intervention: Lamivudine (Drug); Zidovudine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Glaxo Wellcome

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.

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 design: Treatment, Double-Blind, Safety Study

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.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): 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.

Advance Community Health Services Inc, Santurce 00908, Puerto Rico

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

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

Ottawa General Hospital, Ottawa, Ontario, Canada

Toronto Hosp, Toronto, Ontario, Canada

Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 97210, United States

Montreal Gen Hosp, Montreal, Quebec, Canada

Mem Hosp of Rhode Island, Pawtucket, Rhode Island 02860, United States

Nicholaos Bellos, Dallas, Texas 75246, United States

Central Texas Med Foundation, Austin, Texas 78751, United States

Richmond AIDS Consortium, Richmond, Virginia 23219, United States

Wisconsin Community - Based Research Consortium, Milwaukee, Wisconsin 53202, United States

Related publications:

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.

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.

Last updated: December 8, 2005