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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002420
Recruitment Status : Terminated
First Posted : August 31, 2001
Last Update Posted : August 14, 2008
Sponsor:
Collaborators:
Pharmacia and Upjohn
Triangle Pharmaceuticals
Information provided by:
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE August 31, 2001
Last Update Posted Date August 14, 2008
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Emivirine
  • Drug: Hydroxyurea
  • Drug: Delavirdine mesylate
  • Drug: Stavudine
  • Drug: Didanosine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
25
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002420
Other Study ID Numbers  ICMJE 292E
ICC 603
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE
  • Pharmacia and Upjohn
  • Triangle Pharmaceuticals
Investigators  ICMJE Not Provided
PRS Account Bristol-Myers Squibb
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP