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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

HIV Infections

Treatments

Drug: Lamivudine
Drug: Zidovudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002320
129B
NUCA 3001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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