Clinical trial NCT00002334: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Saquinavir
HIV Protease Inhibitors
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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