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

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

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Didanosine Delavirdine Delavirdine mesylate MKC 442 Hydroxyurea Stavudine

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Bristol-Myers Squibb:

Drug Therapy, Combination
Reverse Transcriptase Inhibitors
Anti-HIV Agents

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

Delavirdine
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
Anti-HIV Agents
Antineoplastic Agents
Antisickling Agents

ClinicalTrials.gov processed this record on February 12, 2012