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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

November 2, 1999
February 19, 2009
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Complete list of historical versions of study NCT00004581 on ClinicalTrials.gov Archive Site
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A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
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

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).

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.
Interventional
Phase 3
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Lopinavir/Ritonavir
  • Drug: Nevirapine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
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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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Brazil,   Canada,   Denmark,   France,   Germany,   Poland,   Puerto Rico,   South Africa,   Spain,   Switzerland,   United Kingdom
 
NCT00004581
285D, M98-888
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Abbott
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Abbott
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP