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

AIDS-related Kaposi's Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834457
• Other study ID #: COL30512
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 2, 2009
• Last updated: October 29, 2014
• Start date: June 2007
• Est. completion date: July 2009

Study information

• Verified date: October 2014
• Source: Parirenyatwa Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zimbabwe: Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS-related Kaposi's Sarcoma
• AIDS-Related Opportunistic Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Zimbabwe	University of Zimbabwe College of Health Sciences Department of Medicine	Harare

Sponsors (4)

Lead Sponsor	Collaborator
Parirenyatwa Hospital	Abbott, GlaxoSmithKline, University of Colorado, Denver

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		96 weeks	Yes