A Study of MKC-442 in HIV-Positive Patients

NCT00002413 | Completed Phase 2

• 2 other identifiers: 292BMKC-304
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to see if it is safe and effective to give MKC-442 plus at least two other anti-HIV drugs to patients who have never been treated with nonnucleoside reverse transcriptase inhibitors but who have been treated with nucleoside reverse transcriptase inhibitors and protease inhibitors. This study also determines how long a drug combination including MKC-442 is effective.

Conditions

HIV Infections

Keywords

Anti-HIV Agents; Viral Load; MKC 442

Interventions

Emivirine 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 plasma, administration of at least 2 available antiviral agents by prescription may be given with MKC-422.
• Patients must have:
• \- HIV infection with HIV-1 RNA greater than or equal to 2,000 by Roche Amplicor method, 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.
• 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 the listed laboratory values.
• Prior Medication:
• Excluded:
• Non-nucleoside reverse transcriptase inhibitor therapy.
• Any unapproved experimental antiretroviral 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.
• Risk Behavior:

Sponsors & Collaborators

• Triangle Pharmaceuticals: lead

MeSH Terms

Conditions

HIV Infections

Interventions

emivirine

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• 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