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A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors Clinical research trials and A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors. A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors  A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors
A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors
For Condition: HIV Infections
Status: Completed
Sponsor(s): Merck , Agouron Pharmaceuticals
Synopsis: Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).
Details: Patients receive a treatment regimen consisting of nelfinavir, indinavir, and efavirenz for 48 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. After Week 48, patients with documented virologic response are eligible to continue receiving study treatments and to attend scheduled follow-up visits. Patients who experience virologic failure are discontinued from the study.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Are at least 13 years old (consent of parent or guardian required if under 18). - Have a viral load of at least 10,000 copies/ml within 30 days of study entry. - 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 hepatitis. - Have any other serious medical condition besides HIV infection. - Are allergic to indinavir, nelfinavir, or efavirenz. - Have ever taken NNRTIs or protease inhibitors. - Have had chemotherapy or radiation therapy within 30 days of study entry. (Local radiation therapy is allowed.) - Have taken certain other medications that might affect your immune system such as interleukin-2, interferon, or a vaccine within 30 days of study entry. - Are enrolled or plan to enroll in another anti-HIV drug study during this study. - Are pregnant or breast-feeding. - Abuse alcohol or drugs.
Total Enrollment: 6
Location and Contact Information:
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Brown Univ School of Medicine
Providence, Rhode Island, 02908
United States
Pacific Oaks Med Group
Beverly Hills, California, 90211
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Univ of Colorado / Health Science Ctr
Denver, Colorado, 80262
United States
Additional Information:
Study ID Numbers: 259G; ICC 602
Study Start Date:
Record last reviewed: March 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002235
Other Hiv Infections Studies:
1. The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents with Symptomatic HIV Infection
2. A Study of Megestrol Acetate Alone or in Combination with Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss
3. A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible
4. Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
5. The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Virginia Clinical Trials
Other Hampton Clinical Trials
A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors
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