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

NCT00002412 | Completed Phase 2

• 2 other identifiers: 292CMKC-305
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Didanosine; Drug Therapy, Combination; Stavudine; Hydroxyurea; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; MKC 442

Interventions

Emivirine DRUG

Hydroxyurea DRUG

Stavudine DRUG

Didanosine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Triangle Pharmaceuticals: lead

Study Sites (1)

Dr Robert Wallace

St. Petersburg, Florida, 33713, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

emivirine; Hydroxyurea; Stavudine; Didanosine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1999-04

Locations

US (1)