- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002420
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
August 13, 2008 updated by: Bristol-Myers Squibb
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90211
- Pacific Oaks Med Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
August 14, 2008
Last Update Submitted That Met QC Criteria
August 13, 2008
Last Verified
August 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Antineoplastic Agents
- Antisickling Agents
- Stavudine
- Hydroxyurea
- Didanosine
- Delavirdine
- Emivirine
Other Study ID Numbers
- 292E
- ICC 603
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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