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

NCT00834457 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2014-10-30

No results posted yet for this study

Summary

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.

Conditions

  • AIDS-related Kaposi's Sarcoma

Interventions

DRUG

abacavir/3TC/zidovudine

continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg 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

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • Parirenyatwa Hospital

    lead OTHER

Principal Investigators

  • Margaret Z Borok, FRCP · University of Zimbabwe College of Health Sciences Department of Medicine

  • Thomas B Campbell, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Zimbabwe

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00834457 on ClinicalTrials.gov