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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002334
• Other study ID #: 229B
• Secondary ID: SV 14604CSV 1460
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: September 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Saquinavir

• Zidovudine

• Zalcitabine

Locations

Country	Name	City	State
Puerto Rico	San Juan Veterans Administration Med Ctr	San Juan
United States	Massachusetts Gen Hosp	Boston	Massachusetts
United States	Cook County Hosp	Chicago	Illinois
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Univ Hosp of Cleveland / Case Western Reserve Univ	Cleveland	Ohio
United States	Respiratory Associates	Corpus Christi	Texas
United States	N Texas Ctr for AIDS & Clin Rsch	Dallas	Texas
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Thomas Street Clinic / Baylor College of Medicine	Houston	Texas
United States	HIV Wellness Ctr / Univ Med Ctr	Las Vegas	Nevada
United States	Miami Veterans Administration Med Ctr	Miami	Florida
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Tulane Univ Med School	New Orleans	Louisiana
United States	Beth Israel Med Ctr	New York	New York
United States	Harkness Pavilion	New York	New York
United States	Univ of Oklahoma Health Science / Pharmacy Practice	Oklahoma City	Oklahoma
United States	Phoenix Body Positive	Phoenix	Arizona
United States	Novum Inc	Pittsburgh	Pennsylvania
United States	UCD Med Ctr	Sacramento	California
United States	Davies Med Ctr	San Francisco	California
United States	Mount Zion Med Ctr / UCSF	San Francisco	California
United States	Univ of Washington	Seattle	Washington
United States	Pacific Oaks Med Group	Sherman Oaks	California
United States	Sunnyvale Med Clinic	Sunnyvale	California
United States	Howard Univ	Washington	District of Columbia
United States	Novum Inc	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Collier CA, Coombs RW, Schoenfeld DA, Bassett R, Hooper C, Timphone J, Baruch A, Corey L. A comparative study of saquinavir (SAQ), and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. SAQ, ZDV, and ddC. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:60