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
  Purpose

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.


Condition Intervention Phase
AIDS-Related Kaposi's Sarcoma
Drug: abacavir/3TC/zidovudine
Drug: abacavir /3TC plus ritonavir boosted lopinavir
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe

Resource links provided by NLM:


Further study details as provided by Parirenyatwa Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 49
Study Start Date: June 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2A
co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg po(Trizivir)one tablet twice daily(BID)for 96 weeks
Drug: abacavir/3TC/zidovudine
continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks
Other Name: Trizivir
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
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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00834457

Locations
Zimbabwe
University of Zimbabwe College of Health Sciences Department of Medicine
Harare, Zimbabwe
Sponsors and Collaborators
Parirenyatwa Hospital
University of Colorado, Denver
GlaxoSmithKline
Abbott
Investigators
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
  More Information

No publications provided

Responsible Party: Dr Margaret Z Borok, University of Zimbabwe College of Health Sciences Department of Medicine
ClinicalTrials.gov Identifier: NCT00834457     History of Changes
Other Study ID Numbers: COL30512
Study First Received: February 2, 2009
Last Updated: February 2, 2009
Health Authority: Zimbabwe: Medical Research Council

Keywords provided by Parirenyatwa Hospital:
AIDS-related Kaposi's sarcoma
antiretroviral therapy

Additional relevant MeSH terms:
Sarcoma, Kaposi
AIDS-Related Opportunistic Infections
Sarcoma
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Opportunistic Infections
Infection
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Parasitic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Zidovudine
Lamivudine
Abacavir
Ritonavir
Lopinavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014