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Completed

NCT Number: NCT00834457

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.

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Key information

Conditions

AIDS-related Kaposi's Sarcoma AIDS-related Kaposi sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Zimbabwe College of Health Sciences Department of Medicine

Harare, Zimbabwe

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

abacavir/3TC/zidovudine

Drug

continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks

Other names: Trizivir

abacavir /3TC plus ritonavir boosted lopinavir

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Parirenyatwa Hospital

Other

Collaborators

  • Abbott
  • GlaxoSmithKline
  • University of Colorado, Denver

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 3, 2009
Registry last updated
Oct 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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