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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002436

Enrollment

325

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

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

Conditions

HIV Infections

Keywords

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

Brief 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.

Detailed 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.

Interventions

DRUGLamivudine

DRUGZidovudine

DRUGZalcitabine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

Canada, Puerto Rico, United States

Outcome results

None listed

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