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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002412
• Other study ID #: 292C
• Secondary ID: MKC-305
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Emivirine

• Hydroxyurea

• Stavudine

• Didanosine

Locations

Country	Name	City	State
United States	Dr Robert Wallace	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Triangle Pharmaceuticals

Country where clinical trial is conducted

United States,