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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.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00004581
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 88 Study Locations
Sponsors and Collaborators
Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004581     History of Changes
Other Study ID Numbers: 285D, M98-888
Study First Received: November 2, 1999
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Drug Therapy, Combination
Nevirapine
HIV Protease Inhibitors
Ritonavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
ABT 378

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
HIV Protease Inhibitors
Lopinavir
Nevirapine
Protease Inhibitors
Reverse Transcriptase Inhibitors
Ritonavir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014