CD4 Cell Recovery in HIV-1 Patients Comparing 2 Treatment Regimes

This study has been completed.
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00966160
First received: August 25, 2009
Last updated: September 28, 2009
Last verified: August 2009

August 25, 2009
September 28, 2009
January 1999
December 2008   (final data collection date for primary outcome measure)
Difference in changes of CD4 cell count between PI and NNRTI groups [ Time Frame: 420 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00966160 on ClinicalTrials.gov Archive Site
  • Evolution of CD4 cell counts [ Time Frame: 420 weeks ] [ Designated as safety issue: No ]
  • Molecular, biochemical and functional markers of CD4 cell apoptosis [ Time Frame: 420 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
CD4 Cell Recovery in HIV-1 Patients Comparing 2 Treatment Regimes
Phase 3, Single Center, Controlled, Investigator-blinded, Randomized Matched Pair Design Study of CD4 Cell Recovery in HIV-1 Patients With Sustained Virologic Response Comparing Protease Inhibitor and Non-nucleoside Reverse Transcriptase Inhibitor Based Treatment Regimes

Therapy guidelines recommend the use of either the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz or a ritonavir-boostered protease inhibitor (PI) plus 2 nucleoside reverse transcriptase inhibitors (NRTI) as first-line treatment regimes of HIV-1 infection. Recent clinical studies suggest potential advantages of NNRTI- over PI-based regimes in therapy initiation due to lower rates of virologic failure and less metabolic side-effects. In contrast, PI regimes were claimed to cause greater increases in CD4 cell count than NNRTI regimes, which has been attributed to intrinsic antiapoptotic effects of the PI. However, it is still unclear whether the immunological response to a PI-containing regime is greater than to an NNRTI-containing regime, whether there is a difference in the extent of reduction of apoptosis between PI and NNRTI regimes and whether a difference in apoptosis is associated with a difference in CD4 cell recovery.

We conducted a controlled, long-term, random matched pair design study in HIV-1 infected individuals under sustained virologic suppression to evaluate in head-to-head comparison the clinical effects of a constant PI-based or NNRTI-based regime on CD4 cell recovery and the underlying molecular, biochemical and functional mechanisms.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Drug: Lopinavir/Ritonavir plus Lamivudine/Zidovudine
    400 mg lopinavir and 100 mg ritonavir (Kaletra capsules, Abbott Laboratories) twice daily plus 150 mg lamivudine (Epivir tablets, GlaxoSmithKline) and 300 mg zidovudine (Retrovir tablets, GlaxoSmithKline) twice daily over 476 weeks
  • Drug: Efavirenz plus Lamivudine/Zidovudine
    600 mg efavirenz (Sustiva tablets, Bristol-Myers Squibb) once daily plus 150 mg lamivudine (Epivir tablets, GlaxoSmithKline) and 300 mg zidovudine (Retrovir tablets, GlaxoSmithKline) twice daily over 476 weeks
  • Active Comparator: PI
    400 mg lopinavir and 100 mg ritonavir (Kaletra capsules, Abbott Laboratories) twice daily plus 150 mg lamivudine (Epivir tablets, GlaxoSmithKline) and 300 mg zidovudine (Retrovir tablets, GlaxoSmithKline) twice daily over a 56-week run-in and a 420-week follow-up
    Intervention: Drug: Lopinavir/Ritonavir plus Lamivudine/Zidovudine
  • Active Comparator: NNRTI
    600 mg efavirenz (Sustiva tablets, Bristol-Myers Squibb) once daily plus 150 mg lamivudine (Epivir tablets, GlaxoSmithKline) and 300 mg zidovudine (Retrovir tablets, GlaxoSmithKline) twice daily over a 56-week run-in and a 420-week follow-up
    Intervention: Drug: Efavirenz plus Lamivudine/Zidovudine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Recent, non-acute HIV-1 infection
  • Caucasians
  • BMI between 17.5 and 30 kg/m2
  • CD4 count <200 cells/µl
  • Plasma viral load >100,000 HIV-1 RNA copies/ml

Exclusion Criteria:

  • Actual or previous antiretroviral therapy
  • Acute illness
  • Coinfection with HBV or HCV
  • Opportunistic infection (Pneumocystis jiroveci pneumonia, Toxoplasma gondii encephalitis, Mycobacterium ssp. infection, syphilis, cryptosporidiosis, cryptococcosis, aspergillosis, cytomegalovirus infection or progressive multifocal leukoencephalopathy)
  • Hepatic or renal disorder
  • Severe cardiovascular disease
  • Hematologic disorder
  • Autoimmune disorder
  • Diabetes mellitus or other severe endocrine disorder
  • Malignancy
  • Neurocognitive disorder
  • Psychiatric disorder
  • Drug or alcohol addiction
  • Chronic drug use (except of blood pressure-lowering or lipid-lowering drugs or proton-pump inhibitors)
  • Any acute medication within 7 days or vaccination within 30 days prior to entry
  • Pregnancy or lactation
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00966160
HIV-1999-LRE
Not Provided
Dirk Taubert, University of Cologne
University of Cologne
Not Provided
Study Director: Dirk Taubert, MD PhD Department of Pharmacology, University of Cologne, Germany
University of Cologne
August 2009

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