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A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

This study has been completed.

Sponsored by: Abbott
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00004581
  Purpose

The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).


Condition Intervention Phase
HIV Infections
Drug: Lopinavir/Ritonavir
Drug: Nevirapine
Phase III

MedlinePlus related topics:   AIDS    AIDS Medicines   

Drug Information available for:   Ritonavir    Nevirapine    Lopinavir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   300

Detailed Description:

Patients receive 1 of the following:

  1. ABT-378/RTV plus NVP plus 2 NRTIs; or
  2. Investigator-selected PI(s) plus NVP plus 2 NRTIs.
  Eligibility
Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 12 years old.
  • Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
  • Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
  • Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
  • Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have an active illness.
  • Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
  • Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
  • Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
  • Have received treatment with a PI other than their current PI.
  • Are receiving chemotherapy for cancer.
  • Are pregnant or breast-feeding.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004581

Show 88 study locations  Show 88 Study Locations

Sponsors and Collaborators
Abbott
  More Information


Study ID Numbers:   285D, M98-888
First Received:   November 2, 1999
ClinicalTrials.gov Identifier:   NCT00004581
Health Authority:   Unspecified

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination  
Nevirapine  
HIV Protease Inhibitors  
Ritonavir  
Reverse Transcriptase Inhibitors
Anti-HIV Agents
ABT 378

Study placed in the following topic categories:
Virus Diseases
Nevirapine
Sexually Transmitted Diseases, Viral
Lopinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008




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