A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment

A Randomized, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002334

Enrollment

3000

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

Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Saquinavir, HIV Protease Inhibitors

Brief summary

To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.

Detailed description

Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.

Interventions

DRUGSaquinavir

DRUGZidovudine

DRUGZalcitabine

Study design

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Concurrent Medication: Allowed: * Erythropoietin and G-CSF. Concurrent Treatment: Allowed: * Local skin radiotherapy. Patients must have: * HIV infection. * CD4 count 50 - 350 cells/mm3. * No prior antiretroviral therapy OR less than 16 weeks of prior AZT. * No acute serious opportunistic infections requiring immediate treatment. * No unexplained fever persisting for 14 days within 90 days prior to study entry. * No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry. * No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy. * Life expectancy of at least 80 weeks.

Exclusion criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Malabsorption. * Severe chronic diarrhea. * Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort). * Any grade 3 or worse toxicity. * Inability to comply with study requirements. Concurrent Medication: Excluded: * Other investigational agents. * Antineoplastic agents. * Biologic response modifiers (including interferons). * Foscarnet. * Anti-HIV drugs other than the study drugs. Concurrent Treatment: Excluded: * Radiotherapy (other than local skin radiotherapy). Patients with the following prior condition are excluded: History of non-Hodgkin's lymphoma. Prior Medication: Excluded: * Acute therapy for opportunistic infection within 14 days prior to study entry. * Prior HIV proteinase inhibitor.

Countries

Puerto Rico, United States

Outcome results

None listed

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