A Study of MKC-442 in Combination With Other Anti-HIV Drugs

A Randomized, Double-Blind Study of MKC-442 Combined With Stavudine, Didanosine, and Hydroxyurea in HIV-Infected Patients Who Are Protease Inhibitor Experienced and Non-Nucleoside Reverse Transcriptase Inhibitor Naive

The purpose of this study is to see if it is safe and effective to give MKC-442 plus stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Stavudine; Drug: Didanosine; Drug: Hydroxyurea; Drug: Emivirine

Detailed Description

Patients are randomized to receive either MKC-442 or placebo, along with stavudine(d4T), didanosine(ddI), and hydroxyurea. Patients will be treated and followed for 48 weeks.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33713
      • Dr Robert Wallace

Participation Criteria

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:

- Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from the plasma, administration of a combination of two or more available antiretroviral agents by prescription may be given with MKC-442.

Patient must have:

• HIV infection with HIV-1 RNA greater than or equal to 5,000 by Roche Amplicor method within 30 days of entry.
• A failed protease inhibitor-containing regimen.
• Negative serum beta human chorionic gonadotropin test within 30 days of entry.

Prior Medication:

Allowed:

• Prior nucleoside reverse transcriptase and protease inhibitors.
• Cytotoxic chemotherapy more than 30 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Malabsorption or severe chronic diarrhea within 30 days prior to entry, or inability to consume adequate oral intake because of chronic nausea, emesis, or abdominal or esophageal discomfort.
• Inadequately controlled seizure disorder.
• Known intolerance to stavudine, didanosine, and/or hydroxyurea.
• Acute and clinically significant medical event within 30 days of screening.
• Any clinical or laboratory abnormality greater than Grade 3 toxicity, with the exception of laboratory values given.

Concurrent Treatment:

Excluded:

- Any experimental antiretroviral therapy or immunomodulators directed against HIV-1, e.g., IL-4, cyclosporine steroids at doses greater than 40 mg/day.

Prior Medication:

Excluded:

- Non-nucleoside reverse transcriptase inhibitor therapy.

Prior Treatment:

Excluded:

• Radiation therapy within 30 days of entry except to a local lesion.
• Transfusion of blood or blood products within 21 days of screening.
• Cytotoxic therapy within 3 months of study entry.

Risk Behavior:

Excluded:

Active substance abuse that may interfere with compliance or protocol evaluations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: Double

Collaborators and Investigators

• Sponsor: Triangle Pharmaceuticals

Study record dates

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: April 1, 1999

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Stavudine; Viral Load; Hydroxyurea; Didanosine; MKC 442
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Antineoplastic Agents; Antisickling Agents; Stavudine; Hydroxyurea; Didanosine; Emivirine
• Other Study ID Numbers: 292C; MKC-305