A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients - Full Text View

A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

This study has been completed.

Sponsored by:	Hoffmann-La Roche
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002178

Purpose

To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.

Condition	Intervention	Phase
HIV Infections	Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Saquinavir Drug: Delavirdine mesylate	Phase III

MedlinePlus related topics:

AIDS

Drug Information available for:

Delavirdine mesylate Delavirdine Nelfinavir Nelfinavir Mesylate Ritonavir Saquinavir Saquinavir mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety Study

Official Title:	A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

375

Detailed Description:

Patients are randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus RTI, and Group C - SQV sgc plus nelfinavir plus RTI (or SQV sgc plus ritonavir plus 2 RTIs).

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

HIV RNA >= 5000 copies/ml by Amplicor assay.
Signed, informed consent from parent or legal guardian for patients less than 18 years old.

Previous treatment with antiretrovirals.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002178

Locations


United States, California
	Dr Charles Farthing
	Los Angeles, California, United States, 90048

United States, Massachusetts
	Community Research Initiative
	Brookline, Massachusetts, United States, 02445

Sponsors and Collaborators

Hoffmann-La Roche

More Information

Publications:

Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8. No abstract available.

Study ID Numbers:	229J, NR15539
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002178
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1

Drug Therapy, Combination

HIV Protease Inhibitors

RNA, Viral

Dosage Forms

Saquinavir

Reverse Transcriptase Inhibitors

Anti-HIV Agents

Viral Load

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Saquinavir

Ritonavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Delavirdine

Nelfinavir

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

HIV Protease Inhibitors

Slow Virus Diseases

Anti-HIV Agents

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Protease Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008