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NCT00002320 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002320
Other study ID # 129B
Secondary ID NUCA 3001
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated December 8, 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 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 320
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lamivudine

• Zidovudine

Locations
Country Name City State
Canada Montreal Gen Hosp Montreal Quebec
Canada Ottawa General Hospital Ottawa Ontario
Canada Toronto Hosp Toronto Ontario
Puerto Rico Advance Community Health Services Inc Santurce
United States AIDS Research Consortium of Atlanta Atlanta Georgia
United States Central Texas Med Foundation Austin Texas
United States CRI of New England Brookline Massachusetts
United States Univ of North Carolina School of Medicine Chapel Hill North Carolina
United States Chicago Ctr for Clinical Research Chicago Illinois
United States Nicholaos Bellos Dallas 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 Mem Hosp of Rhode Island Pawtucket Rhode Island
United States Portland Veterans Adm Med Ctr / Rsch & Education Grp Portland Oregon
United States Richmond AIDS Consortium Richmond Virginia
United States San Diego Community Research Group San Diego California
United States Pacific Oaks Med Group Sherman Oaks California
United States Infectious Disease Research Institute Inc Tampa Florida
United States Med College of Ohio Toledo Ohio
United States Harbor - UCLA Med Ctr Torrance California

Sponsors (1)
Lead Sponsor Collaborator
Glaxo Wellcome

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

References & Publications (2)

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. — View 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. — View Citation

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