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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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Saquinavir (Drug); Zidovudine (Drug); Zalcitabine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

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.

Clinical Details

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

San Juan Veterans Administration Med Ctr, San Juan 009275800, Puerto Rico

Phoenix Body Positive, Phoenix, Arizona 85016, United States

UCD Med Ctr, Sacramento, California 95817, United States

Davies Med Ctr, San Francisco, California 94114, United States

Mount Zion Med Ctr / UCSF, San Francisco, California 94115, United States

Pacific Oaks Med Group, Sherman Oaks, California 91403, United States

Sunnyvale Med Clinic, Sunnyvale, California 94086, United States

Howard Univ, Washington, District of Columbia 20060, United States

Novum Inc, Washington, District of Columbia 20037, United States

Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States

Univ of Miami School of Medicine, Miami, Florida 331361013, United States

Cook County Hosp, Chicago, Illinois 60612, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States

Tulane Univ Med School, New Orleans, Louisiana 701122699, United States

Massachusetts Gen Hosp, Boston, Massachusetts 02114, United States

HIV Wellness Ctr / Univ Med Ctr, Las Vegas, Nevada 89102, United States

Beth Israel Med Ctr, New York, New York 10003, United States

Harkness Pavilion, New York, New York 10032, United States

Univ Hosp of Cleveland / Case Western Reserve Univ, Cleveland, Ohio 44106, United States

Univ of Oklahoma Health Science / Pharmacy Practice, Oklahoma City, Oklahoma 73117, United States

Novum Inc, Pittsburgh, Pennsylvania 152063817, United States

Respiratory Associates, Corpus Christi, Texas 78404, United States

N Texas Ctr for AIDS & Clin Rsch, Dallas, Texas 75219, United States

Univ TX Galveston Med Branch, Galveston, Texas 775550882, United States

Thomas Street Clinic / Baylor College of Medicine, Houston, Texas 77009, United States

Univ of Washington, Seattle, Washington 981224379, United States

Additional Information

Related publications:

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


Last updated: June 23, 2005

Page last updated: August 23, 2015

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