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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002320

Enrollment

320

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine

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.

Interventions

DRUGLamivudine

DRUGZidovudine

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Countries

Canada, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026