Clinical trial NCT00002436: The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Zalcitabine
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: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.

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: San Francisco
country: United States
facility: ViRx Inc
state: California
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: Boston
country: United States
facility: Boston City Hosp / FGH-1
state: Massachusetts
city: East Meadow
country: United States
facility: Nassau County Med Ctr
state: New York
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
city: Charlotte
country: United States
facility: Nalle Clinic
state: North Carolina
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
city: Hershey
country: United States
facility: Milton S Hershey Med Ctr
state: Pennsylvania
city: Austin
country: United States
facility: Central Texas Med Foundation
state: Texas
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Dallas
country: United States
facility: Nicholaos Bellos
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
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: Ponce
country: Puerto Rico
facility: Hosp Regional de Ponce - Area Vieja
Study officials:
References: