CClinicalTrials.gg
Sign In
CompletedNCT00966160Updated Sep 29, 2009

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

A Phase 3 interventional study of Lopinavir/Ritonavir plus Lamivudine/Zidovudine and Efavirenz plus Lamivudine/Zidovudine in Acquired Immunodeficiency Syndrome and HIV Infections, sponsored by University of Cologne. Completed at 1 site in Germany. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2009-09-29.

Sponsored by University of Cologne · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
215
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acquired Immunodeficiency Syndrome
  • HIV Infections

Keywords

  • treatment naive
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 215 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

University of Cologne is the lead sponsor of 199 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
215 participants (actual)

Study arms

  • 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

    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

    Drug: Efavirenz plus Lamivudine/Zidovudine

Interventions

  • DrugLopinavir/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

  • DrugEfavirenz 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

06

What researchers measure

Primary outcomes

  1. Difference in changes of CD4 cell count between PI and NNRTI groups

    Time frame: 420 weeks

Secondary outcomes

  1. Evolution of CD4 cell counts

    Time frame: 420 weeks

  2. Molecular, biochemical and functional markers of CD4 cell apoptosis

    Time frame: 420 weeks

07

Study locations

1 site
  • Medical Clinic I and Department of Pharmacology, University of Cologne
    Cologne, Germany
08

References and documents

Publications

  • Riddler SA, Haubrich R, DiRienzo AG, Peeples L, Powderly WG, Klingman KL, Garren KW, George T, Rooney JF, Brizz B, Lalloo UG, Murphy RL, Swindells S, Havlir D, Mellors JW; AIDS Clinical Trials Group Study A5142 Team. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med. 2008 May 15;358(20):2095-106. doi: 10.1056/NEJMoa074609. PubMed 18480202 ↗
  • Staszewski S, Morales-Ramirez J, Tashima KT, Rachlis A, Skiest D, Stanford J, Stryker R, Johnson P, Labriola DF, Farina D, Manion DJ, Ruiz NM. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. Study 006 Team. N Engl J Med. 1999 Dec 16;341(25):1865-73. doi: 10.1056/NEJM199912163412501. PubMed 10601505 ↗
  • Badley AD, Pilon AA, Landay A, Lynch DH. Mechanisms of HIV-associated lymphocyte apoptosis. Blood. 2000 Nov 1;96(9):2951-64. PubMed 11049971 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00966160
Lead sponsor
University of Cologne
First posted
Aug 26, 2009
Start date
Jan 1999
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Sep 29, 2009

Study contacts

Dirk Taubert, MD PhD
study director · Department of Pharmacology, University of Cologne, Germany
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

HIV Infections→

Other studies from this sponsor

University of Cologne

Start the discussion