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| Sponsor: | Triangle Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002413 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Emivirine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | An Open Label Study of MKC-442 in at Least Triple Drug Combination in Patients Previously Treated With Nucleoside Reverse Transcriptase and Protease Inhibitors and Who Are Naive to Non-Nucleoside Reverse Transcriptase Inhibitors |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Risk Behavior:
Excluded:
Active substance abuse that may interfere with compliance or protocol evaluations.
Contacts and Locations
More Information
| Study ID Numbers: | 292B, MKC-304 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002413 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-HIV Agents Viral Load MKC 442 |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Nucleic Acid Synthesis Inhibitors |