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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 Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about 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 conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like 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. 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 Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often get the best healthcare available for their 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 condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections
Status: Terminated
Sponsor(s): Boehringer Ingelheim Pharmaceuticals , Bristol-Myers Squibb,Triangle Pharmaceuticals
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 25
Location and Contact Information:
Pacific Oaks Med Group
Beverly Hills, California, 90211
United States
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262
United States
Brown Univ School of Medicine
Providence, Rhode Island, 02908
United States
Additional Information:
Study ID Numbers: 292D; ICC 601
Study Start Date:
Record last reviewed: March 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002418
Other Hiv Infections Studies:
1. A Study of Didanosine Use Alone or in Combination with Zidovudine in Infants Exposed to or Infected with HIV
2. Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients with Persistent Generalized Lymphadenopathy
3. Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients with AIDS or Advanced ARC
4. Treatment of Hepatitis in Patients who are Triple-Infected with HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
5. Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Beverly Hills Clinical Trials
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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