The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT

Condition(s) targeted: HIV Infections

Intervention: Lamivudine (Drug); Zidovudine (Drug); Zalcitabine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Glaxo Wellcome

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.

Official title: 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

Study design: Treatment, Safety Study

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

Hosp Regional de Ponce - Area Vieja, Ponce 00731, Puerto Rico

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

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

Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10019, United States

Nassau County Med Ctr, East Meadow, New York 11554, United States

Nalle Clinic, Charlotte, North Carolina 28207, United States

Duke Univ Med Ctr, Durham, North Carolina 27710, 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

Milton S Hershey Med Ctr, Hershey, Pennsylvania 17033, United States

Montreal Gen Hosp, Montreal, Quebec, Canada

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

Last updated: June 23, 2005