A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Parirenyatwa Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Colorado, Denver
GlaxoSmithKline
Abbott
Information provided by:
Parirenyatwa Hospital
ClinicalTrials.gov Identifier:
NCT00834457
First received: February 2, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 2, 2009
February 2, 2009
June 2007
July 2009   (final data collection date for primary outcome measure)
Compare effects of twice-daily all-(NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a protease inhibitor AIDS-KS subjects with good virologic suppression on all-NRTI regimen. [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe

Open-label study of a regimen of antiretrovirals for the treatment of AIDS-KS. This study will be conducted at a single site, the Parirenyatwa Hospital KS Clinic.

Step 1 was conducted to determine the extent of clinical resolution of AIDS-KS disease in response to treatment with antiretroviral therapy and to investigate whether clinical resolution of KS is associated with suppression of KSHV replication.

Step 2 was developed to then evaluate the clinical, immunological, and virological effects of a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in persons with AIDS-KS and good virologic suppression an all NRTI regimen.

Step 3 was included to evaluate the clinical, immunological, and virological effects of intensification with a ritonavir-boosted protease inhibitor in persons with AIDS-KS who have virological failure on an all NRTI regimen.

To identify factors associated with successful treatment of KS with antiretroviral therapy and to determine if highly active antiretroviral therapy improves survival and quality of life for persons with AIDS-KS in Zimbabwe.

A secondary objective is to investigate the durability of HIV-1 suppression by the combination of ABC/3TC/ZDV in persons infected with HIV-1 subtype C and to evaluate the timing and characteristics of mutations in HIV-1 reverse transcriptase in subjects who fail to achieve, or to maintain suppression of HIV-1 replication during treatment with ABC/3TC/ZDV.

An important objective is to assess adherence to a simplified antiretroviral regimen in a resource-limited setting.

The study will evaluate the clinical, immunological, and virological effects of a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in persons with AIDS-KS and good virologic suppression on ABC/3TC/ZDV (see above).

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
AIDS-Related Kaposi's Sarcoma
  • Drug: abacavir/3TC/zidovudine
    continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks
    Other Name: Trizivir
  • Drug: abacavir /3TC plus ritonavir boosted lopinavir
    fixed dose abacavir 600mg/3TC 300mg one tablet po QD for 96 weeks plus fixed dose ritonavir 33.3mg/lopinavir 133.3mg four tablets po QD for 96 weeks
    Other Names:
    • Kivexa or Epzicom
    • Aluvia
  • Active Comparator: 2A
    co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg po(Trizivir)one tablet twice daily(BID)for 96 weeks
    Intervention: Drug: abacavir/3TC/zidovudine
  • Active Comparator: 2B
    co-formulated abacavir 600mg/3TC 300mg orally (as Kivexa) one tablet daily plus fixed dose lopinavir 133.3mg/ritonavir 33.3mg orally (as Aluvia) four tablets daily for 96 weeks
    Intervention: Drug: abacavir /3TC plus ritonavir boosted lopinavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
49
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:Completion of at least 96 weeks of treatment with ABC/3TC/ZDV on protocol Step 1.

  • Currently receiving ABC/3TC/ZDV on Step 1/initial open-label allNRTI phase of study.
  • Plasma HIV-1 RNA < 400 copies/mL on the most recent plasma HIV-1 RNA performed within 4 weeks of Step 2 entry.
  • Willing to potentially switch to a new antiretroviral regimen.
  • In the opinion of the site investigator currently has clinical evidence of active KS disease.

Exclusion Criteria

  • None
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Zimbabwe
 
NCT00834457
COL30512
Yes
Dr Margaret Z Borok, University of Zimbabwe College of Health Sciences Department of Medicine
Parirenyatwa Hospital
  • University of Colorado, Denver
  • GlaxoSmithKline
  • Abbott
Principal Investigator: Margaret Z Borok, FRCP University of Zimbabwe College of Health Sciences Department of Medicine
Study Chair: Thomas B Campbell, MD University of Colorado, Denver
Parirenyatwa Hospital
February 2009

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