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A Study of MKC-442 in HIV-Positive Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002413
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1999
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002413     History of Changes
Other Study ID Numbers: 292B, MKC-304
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Anti-HIV Agents
Viral Load
MKC 442

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Reverse Transcriptase Inhibitors
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014