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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Emivirine (Drug); Hydroxyurea (Drug); Stavudine (Drug); Didanosine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Triangle Pharmaceuticals

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.

Clinical Details

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

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Dr Robert Wallace, St. Petersburg, Florida 33713, United States
Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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