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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study has been completed.

Study NCT00002320. Last updated on December 8, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past
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
Brief 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.
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.
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Treatment, Double-Blind, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Lamivudine Drug: Zidovudine
MEDLINE PMIDs	9030391, 8853730
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	320
Start Date ^†
Completion Date
Eligibility 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.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Canada, Puerto Rico

Administrative Information Fields
NCT ID ^†	NCT00002320
Organization ID	129B
Secondary IDs ^††	NUCA 3001
Study Sponsor ^†	Glaxo Wellcome
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	May 1994
First Received Date ^†	November 2, 1999
Last Updated Date	December 8, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.