A Study of MKC-442 in HIV-Positive Patients
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999
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.
||Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
||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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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 nucleoside reverse transcriptase and protease inhibitors.
- Cytotoxic chemotherapy more than 30 days prior to entry.
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.
- Non-nucleoside reverse transcriptase inhibitor therapy.
- Any unapproved experimental antiretroviral therapy.
- Radiation therapy within 30 days of entry, except to a local lesion.
- Transfusion of blood or blood products within 21 days of screening.
Active substance abuse that may interfere with compliance or protocol evaluations.
No Contacts or Locations Provided
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors