- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002203
A Study of Two Anti-HIV Drug Combinations
A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients
The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs.
Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.
Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Santurce, Puerto Rico, 00907
- San Juan AIDS Program
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California
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Beverly Hills, California, United States, 90211
- Pacific Oaks Med Ctr
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Los Angeles, California, United States, 90048
- Tower Infectious Diseases / Med Associates Inc
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Univ of North Carolina Hosps
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Charlotte, North Carolina, United States, 28232
- Carolinas Med Ctr
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Virginia
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Annandale, Virginia, United States, 22003
- Infectious Diseases Physicians Inc
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Univ of Wisconsin School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
- HIV infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.
- CD4+ cell count of at least 300 cells/mm3.
- HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.
- CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).
- Compliance with dosing schedule and protocol evaluations.
Prior Medication:
Required:
- 3TC at 150 mg bid, ZDV at 600 mg/day (200 mg tid or 300 mg bid), plus a marketed protease inhibitor (ritonavir, saquinavir, indinavir, or nelfinavir) at its recommended dose for at least 10 weeks.
Allowed:
- Inhaled corticosteroids for the treatment of asthma.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).
- Enrollment in other investigational protocols.
Concurrent Medication:
Excluded:
- Cytotoxic chemotherapeutic agents.
- Nonnucleoside reverse transcriptase inhibitors.
- Other investigational agents.
Concurrent Treatment:
Excluded:
Radiation therapy.
Prior Medication:
Excluded:
- Cytotoxic chemotherapeutic and immunomodulating agents such as systemic corticosteroids, IF-2, alpha-IFN, beta-IFN, or gamma-IFN (except for inhaled corticosteroids for the treatment of asthma) within 4 weeks of study entry.
- HIV immunotherapeutic vaccine within 3 months of study entry.
Prior Treatment:
Excluded:
Radiation therapy within 4 weeks of study entry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Lamivudine
- Zidovudine
- Lamivudine, zidovudine drug combination
Other Study ID Numbers
- 280A
- NZTA4001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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