Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00001993
• Lead Sponsor: G D Searle

Brief Summary

The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+ cells/mm3.

The secondary objective is to determine the pharmacokinetics and bioavailability of both SC-48334 and AZT, when administered together, in symptomatic HIV+ patients with 200 - 500 CD4+ cells/mm3.

Detailed Description

Not available

Study Timeline

• Status Verified: 1992-02
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Rush Presbyterian - Saint Luke's Med Ctr; 🇺🇸 Chicago, Illinois, United States

Univ of Miami School of Medicine; 🇺🇸 Miami, Florida, United States

Infectious Diseases Research Clinic / Indiana Univ Hosp; 🇺🇸 Indianapolis, Indiana, United States

Ohio State Univ Hosp Clinic; 🇺🇸 Columbus, Ohio, United States

Univ of Washington; 🇺🇸 Seattle, Washington, United States

Julio Arroyo; 🇺🇸 West Columbia, South Carolina, United States