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NCT00002436 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002436
Other study ID # 129C
Secondary ID NUCA 3002
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date May 1994
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 325
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lamivudine

• Zidovudine

• Zalcitabine

Locations
Country Name City State
Canada Montreal Gen Hosp Montreal Quebec
Canada Ottawa General Hospital Ottawa Ontario
Canada Toronto Hosp Toronto Ontario
Puerto Rico Hosp Regional de Ponce - Area Vieja Ponce
United States AIDS Research Consortium of Atlanta Atlanta Georgia
United States Central Texas Med Foundation Austin Texas
United States Boston City Hosp / FGH-1 Boston Massachusetts
United States Nalle Clinic Charlotte North Carolina
United States Chicago Ctr for Clinical Research Chicago Illinois
United States Nicholaos Bellos Dallas Texas
United States Univ of Texas Southwestern Med Ctr of Dallas Dallas Texas
United States Duke Univ Med Ctr Durham North Carolina
United States Nassau County Med Ctr East Meadow New York
United States Milton S Hershey Med Ctr Hershey Pennsylvania
United States Houston Clinical Research Network Houston Texas
United States Combat Group Los Angeles California
United States Wisconsin Community - Based Research Consortium Milwaukee Wisconsin
United States Louisiana Cardiovascular Research Ctr New Orleans Louisiana
United States Saint Luke's - Roosevelt Hosp Ctr New York New York
United States Portland Veterans Adm Med Ctr / Rsch & Education Grp Portland Oregon
United States San Diego Community Research Group San Diego California
United States ViRx Inc San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Glaxo Wellcome

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

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