Expired Study
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Miami, Florida 33125


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

229B


NCT ID:

NCT00002334


Secondary ID:

SV 14604C


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Masking:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

3000


Enrollment Type:


Study Dates

Verification Date:September 1996
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Saquinavir
Intervention Type:Drug
Name:Zidovudine
Intervention Type:Drug
Name:Zalcitabine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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