A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
NCT ID: NCT00834457
Last Updated: 2014-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
49 participants
INTERVENTIONAL
2007-06-30
2009-07-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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2A
co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg po(Trizivir)one tablet twice daily(BID)for 96 weeks
abacavir/3TC/zidovudine
continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks
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
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
Interventions
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abacavir/3TC/zidovudine
continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
GlaxoSmithKline
INDUSTRY
Abbott
INDUSTRY
Parirenyatwa Hospital
OTHER
Responsible Party
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Margaret Borok
Principal Investigator
Principal Investigators
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Margaret Z Borok, FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Zimbabwe College of Health Sciences Department of Medicine
Thomas B Campbell, MD
Role: STUDY_CHAIR
University of Colorado, Denver
Locations
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University of Zimbabwe College of Health Sciences Department of Medicine
Harare, , Zimbabwe
Countries
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Other Identifiers
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COL30512
Identifier Type: -
Identifier Source: org_study_id
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