A Study of MKC-442 in Combination With Other Anti-HIV Drugs

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002412
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 stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.


Condition Intervention Phase
HIV Infections
Drug: Emivirine
Drug: Hydroxyurea
Drug: Stavudine
Drug: Didanosine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study of MKC-442 Combined With Stavudine, Didanosine, and Hydroxyurea in HIV-Infected Patients Who Are Protease Inhibitor Experienced and Non-Nucleoside Reverse Transcriptase Inhibitor Naive

Resource links provided by NLM:


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

Detailed Description:

Patients are randomized to receive either MKC-442 or placebo, along with stavudine(d4T), didanosine(ddI), and hydroxyurea. Patients will be treated and followed for 48 weeks.

  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 the plasma, administration of a combination of two or more available antiretroviral agents by prescription may be given with MKC-442.

Patient must have:

  • HIV infection with HIV-1 RNA greater than or equal to 5,000 by Roche Amplicor method within 30 days of entry.
  • A failed protease inhibitor-containing regimen.
  • Negative serum beta human chorionic gonadotropin test 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.
  • Known intolerance to stavudine, didanosine, and/or hydroxyurea.
  • 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 laboratory values given.

Concurrent Treatment:

Excluded:

- Any experimental antiretroviral therapy or immunomodulators directed against HIV-1, e.g., IL-4, cyclosporine steroids at doses greater than 40 mg/day.

Prior Medication:

Excluded:

- Non-nucleoside reverse transcriptase inhibitor 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.
  • Cytotoxic therapy within 3 months of study entry.

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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002412

Locations
United States, Florida
Dr Robert Wallace
St. Petersburg, Florida, United States, 33713
Sponsors and Collaborators
Triangle Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002412     History of Changes
Other Study ID Numbers: 292C, MKC-305
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:
Didanosine
Drug Therapy, Combination
Stavudine
Hydroxyurea
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
MKC 442

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

ClinicalTrials.gov processed this record on August 18, 2014