Back to resultsThe Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors
Primary Purpose
HIV Infections
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Emivirine
Hydroxyurea
Nevirapine
Stavudine
Didanosine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are at least 18 years old. Are HIV-positive. 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 serious medical conditions, including pancreatitis, neuropathy, untreated seizures, or AIDS-related cancers, except Kaposi's sarcoma (KS). Are enrolled in another anti-HIV drug study while participating in this study. Have ever taken NNRTIs (such as NVP or MKC-442). Have ever taken ddI or d4T. Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system (such as corticosteroids, interleukin-2, or interferon). Abuse alcohol or drugs. Have received chemotherapy or radiation therapy within 30 days prior to study entry. (Local radiation therapy is allowed.) Are allergic to any of the study drugs. Are pregnant or breast-feeding.
Sites / Locations
- Pacific Oaks Med Group
- Univ of Colorado / Health Science Ctr
- AIDS Research Consortium of Atlanta
- Brown Univ School of Medicine
- Hampton Roads Med Specialists
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00002418
First Posted
November 2, 1999
Last Updated
August 13, 2008
Sponsor
Bristol-Myers Squibb
Collaborators
Boehringer Ingelheim, Triangle Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00002418
Brief Title
The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors
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), Viramune (Nevirapine), and MKC-442 (With or Without Hydroxyurea) for the Treatment of HIV-1 Infection in Non-Nucleoside Reverse Transcriptase Inhibitor Naive Patients Who Failed Previous Protease Inhibitor Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2000
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Boehringer Ingelheim, Triangle Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.
Detailed Description
Patients receive a regimen of didanosine, stavudine, nevirapine, and MKC-442 for 24 weeks. Throughout 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. Patients who experience virologic failure have the option of adding hydroxyurea to their treatment regimen or discontinuing from the study. After Week 24, patients with documented virologic response may continue treatment with didanosine, stavudine, nevirapine, and MKC-442, and, if applicable, hydroxyurea until a change in virologic status occurs (i.e., the patient experiences virologic failure). Follow-up visits are conducted every 4 to 12 weeks until permanent discontinuation from the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Emivirine
Intervention Type
Drug
Intervention Name(s)
Hydroxyurea
Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Didanosine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
Are at least 18 years old.
Are HIV-positive.
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 serious medical conditions, including pancreatitis, neuropathy, untreated seizures, or AIDS-related cancers, except Kaposi's sarcoma (KS).
Are enrolled in another anti-HIV drug study while participating in this study.
Have ever taken NNRTIs (such as NVP or MKC-442).
Have ever taken ddI or d4T.
Have taken certain medications within 30 days prior to study entry, including medications that affect your immune system (such as corticosteroids, interleukin-2, or interferon).
Abuse alcohol or drugs.
Have received chemotherapy or radiation therapy within 30 days prior to study entry. (Local radiation therapy is allowed.)
Are allergic to any of the study drugs.
Are pregnant or breast-feeding.
Facility Information:
Facility Name
Pacific Oaks Med Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Univ of Colorado / Health Science Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Brown Univ School of Medicine
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors
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