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

June 23, 2005 updated by: G D Searle

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ of Miami School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Infectious Diseases Research Clinic / Indiana Univ Hosp
    • Ohio
      • Columbus, Ohio, United States, 432101228
        • Ohio State Univ Hosp Clinic
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Julio Arroyo
    • Washington
      • Seattle, Washington, United States, 981224304
        • Univ of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Medications for the prophylaxis of opportunistic infections, such as:
  • Aerosolized pentamidine.
  • Trimethoprim/sulfamethoxazole.
  • Nystatin.
  • Clotrimazole.
  • Anti-mycobacterial agents.
  • Ganciclovir.
  • Topical acyclovir.

Patients must have the following:

  • CD4+ cells counts = or > 200 < 500 /cell mm3.
  • For purposes of inclusion the absolute CD4+ cell count must be = or > 200 < 500 cells/mm3 on the first sample and = or > 190 < 510 cells/mm3 on the second sample.
  • Have at least one of the following:
  • Oral candidiasis.
  • Herpes zoster during the last 3 years.
  • Oral hairy leukoplakia during the past three years.
  • Chronic ( > 30 day period), recurrent seborrheic dermatitis, or topical, pruritic folliculitis (itchy bumps).
  • Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight.
  • Chronic fatigue present for the past 6 months, which has interfered with normal activity at least 1 to 2 times per week.
  • HIV antibody positive as determined by federally licensed Enzyme-linked Immunosorbent Assay (ELISA).
  • Documented, written informed consent must be obtained prior to admission to the study.

Prior Medication:

Allowed for no more than 12 weeks prior to study entry:

  • Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Malignancies, with the exception of basal cell carcinoma.
  • Significant organ dysfunction.

Concurrent Medication:

Excluded:

  • All anti-retroviral drugs with the exception of Zidovudine. Cancer chemotherapeutic agents.
  • Anti-metabolites and alkylating agents.
  • All investigational non-FDA approved drugs.

Patients with the following are excluded:

  • Clinically significant diarrhea (> 3 liquid stools per day for > 7 days) without definable cause, within 6 months prior to enrollment).
  • Diarrhea, as above, with known, non-HIV related cause occurring within one month prior to enrollment.
  • Meets CDC criteria for AIDS classification.
  • Chronic fever (> 38.5 C persisting for more than 14 consecutive days, or for more than 15 days in any 30-day interval prior to study entry).
  • Malignancies, with the exception of basal cell carcinoma.
  • Significant organ dysfunction.
  • Known hypersensitivity to SC-48334 or related compounds.
  • History of lactose intolerance.

Prior Medication:

Excluded within 30 days of study entry:

  • Any investigational medication.
  • Treatment with a drug (other than Zidovudine) with anti-HIV activity.
  • Excluded for > 12 weeks prior to study entry:
  • Zidovudine (AZT).
  • Excluded within 90 days of study entry:
  • Ribavirin.
  • Excluded within 6 months of study entry:
  • Cancer chemotherapy.
  • Excluded:
  • Treatment with SC-48334.

Prior Treatment:

Excluded within 30 days of study entry:

  • Electron beam radiation.
  • Excluded within 6 months prior to study entry:
  • Required HIV-related blood transfusions.
  • Whole body radiation.

Current use of illicit substances; or current abuse of alcohol, the use of which would limit compliance with the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G D Searle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

February 1, 1992

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 057A
  • NS8-90-02-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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