HIV Infections
Conditions
Keywords
Anti-HIV Agents, Viral Load, MKC 442
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.
Interventions
DRUGEmivirine
Sponsors
Triangle Pharmaceuticals
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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.
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. * 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: Excluded: Active substance abuse that may interfere with compliance or protocol evaluations.
Outcome results
None listed