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A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment



A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment

For Condition: HIV Infections
Status: Completed
Sponsor(s): Glaxo Wellcome ,
Synopsis: The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.
Details: In this open-label study antiretroviral-naive patients are randomized to one of two drug regimens: Arm I: 141W94 (amprenavir), 1592U89 (abacavir), and Combivir (3TC/AZT tablet). Arm II: Nelfinavir and Combivir.
Eligibility:
Study Type:
  Interventional, Treatment, Open Label, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - CD4 count > 50. - HIV RNA > 5,000. - No active AIDS (excluding CD4 count < 200). - Ability to comply with dosing schedule and protocol evaluations. Prior Medication: Allowed: - 3TC or any protease inhibitor, if < 1 week of therapy. - Other nucleoside analogs, if < 4 weeks of therapy. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: - Active AIDS (not including CD4 count < 200). - Malabsorption syndrome affecting drug absorption. Concurrent Medication: Excluded: Enrollment in any other investigational drug protocol. Prior Medication: Excluded: Non-nucleoside reverse transcriptase inhibitors.
Total Enrollment: 

Location and Contact Information:

Anderson Clinical Research
Pittsburgh,  Pennsylvania,  15213
United States
 


Additional Information:
Study ID Numbers:
  280C;  UNAP 11,NZTA 4002
Study Start Date: 
Record last reviewed: May 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002216

Other Hiv Infections Studies:
1. A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients with AIDS Who Take Daily Multivitamin and Mineral Supplements

2. A Study on the Safety and Anti-HIV Activity of HE2000 in HIV-Infected Patients on Salvage Therapy

3. A Phase I Study to Evaluate the Pharmacokinetics, Safety and Antiviral Effects of Concurrent Administration of Zidovudine (AZT) and 2'3'-Dideoxyinosine (ddI) in Patients With Human Immunodeficiency Virus (HIV)

4. The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children

5. The Use of Bacteriophage phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo

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A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment

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