The Safety and Effectiveness of Didanosine Plus Stavudine Plus Delavirdine Mesylate Plus MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors - Full Text View

Purpose

The purpose of this study is to see if it is safe and effective to give MKC-442, didanosine (ddI), stavudine (d4T), and delavirdine (DLV) to HIV-positive patients.

Condition	Intervention	Phase
HIV Infections	Drug: Emivirine Drug: Hydroxyurea Drug: Delavirdine mesylate Drug: Stavudine Drug: Didanosine	Phase II

MedlinePlus related topics:

AIDS

Drug Information available for:

Delavirdine mesylate Delavirdine Didanosine Stavudine Hydroxyurea MKC 442

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Pharmacokinetics Study

Official Title:	A Phase II, 24-Week, Open-Label Study Designed to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Novel Combination Therapy With Videx (Didanosine), Zerit (Stavudine), Rescriptor (Delavirdine Mesylate), and MKC-442 (With or Without Hydroxyurea) for the Treatment of HIV-1- Infected Patients Who Failed Previous Protease Inhibitor Treatment

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:

25

Detailed Description:

Patients receive a treatment regimen consisting of didanosine, stavudine, delavirdine, and MKC-442 for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Samples for population pharmacokinetics are collected from all patients every 4 weeks. Patients who experience virologic failure may add hydroxyurea to their treatment regimen or be discontinued from the study. Patients who add hydroxyurea to their regimen and subsequently experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving study treatment until their plasma HIV-1 RNA levels return to baseline levels. For patients receiving hydroxyurea beginning at Week 24, visits are conducted at Weeks 28, 32, 36, and every 12 weeks thereafter. For patients who continue taking didanosine, stavudine, delavirdine, and MKC-442 or who have started hydroxyurea treatment between Weeks 12 and 20, follow-up visits are conducted every 12 weeks, or sooner if needed, until the patient permanently discontinues study treatment.

Eligibility

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

Criteria

Inclusion Criteria

You may be eligible for this study if you:

Are HIV-positive.
Are at least 18 years old.
Have experienced treatment failure on a previous anti-HIV drug combination that contained at least one protease inhibitor. Your viral load must be between 5,000 and 50,000 copies/ml after 6 months of continuous treatment with that drug combination.
Agree to use a barrier method of birth control, such as condoms, during the study.

Exclusion Criteria

You will not be eligible for this study if you:

Have a history of certain medical conditions, such as pancreatitis, peripheral neuropathy, seizure disorder, or AIDS-related cancer (except for Kaposi's sarcoma).
Are allergic to any of the study drugs.
Have ever taken certain anti-HIV medications including non-nucleoside reverse transcriptase inhibitors (NNRTIs), ddI, or d4T.
Have taken certain other medications including interleukin-2, interferon or a vaccine within 30 days of study entry.
Have received radiation therapy or chemotherapy within 30 days of study entry. (Local radiation therapy is allowed.)
Abuse alcohol or drugs.
Are pregnant or breast-feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002420

Locations


United States, California
	Pacific Oaks Med Group
	Beverly Hills, California, United States, 90211

Sponsors and Collaborators

Bristol-Myers Squibb

Pharmacia and Upjohn

Triangle Pharmaceuticals

More Information

Study ID Numbers:	292E, ICC 603
First Received:	November 2, 1999
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00002420
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Drug Therapy, Combination

Reverse Transcriptase Inhibitors

Anti-HIV Agents

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

Stavudine

Didanosine

Hydroxyurea

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Delavirdine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Antisickling Agents

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Hematologic Agents

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008

Sponsors and Collaborators:	Bristol-Myers Squibb Pharmacia and Upjohn Triangle Pharmaceuticals
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00002420