CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 112 enrolled
Drug / intervention
Generic HAART Triomune : d4T, 3TC, NVP +1 moredrug
Likely dose
Generic HAART Triomune : d4T, 3TC, NVP 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00380770
NCT00380770Phase 4Completed

A Prospective Randomized Trial Comparing the Response of HIV Kaposi's Sarcoma (KS) to HAART Versus the Combination of HAART and Chemotherapy (CXT)

University of KwaZulu·interventional·Posted Sep 26, 2006·Updated Jul 21, 2010

In Brief

A Phase 4 clinical trial evaluating Generic HAART Triomune : d4T, 3TC, NVP and Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV for HIV and 3 related conditions. Completed, enrolled 112 participants across 1 site.

Detailed Summary

Kaposi's sarcoma (KS)is the commonest malignancy associated with HIV/AIDS. Therapy for this cancer, which causes substantial morbidity, is suboptimal in resource poor settings. The reasons for this are: advanced state of immunosuppression when patients present for clinical care, concomitant opportunistic infections, non- availability of antiretroviral therapy (ART), non-availability and toxicity of chemotherapy (CXT), when available, in patients with full blown AIDS, prohibitive costs of bone marrow support and fiscal constraints in resource poor settings. A recent Cochrane Review assessed the effectiveness of current therapeutic regimens for HIV KS, with a focus on options available in resource poor settings. The major selection criteria for this review were randomized controlled trials for HIV KS in adults. The main conclusions were that data from randomized controlled trials on effective treatments for HIV KS are sparse, particularly among people who are also taking highly active antiretroviral therapy (HAART). Alitretinoin gel is effective for therapy of cutaneous lesions, pegylated liposomal doxorubicin is effective for advanced KS and radiotherapy is effective for treating cutaneous lesions. Apart from the randomized trial of radiotherapy, no trials applicable to developing settings were identified. Therapy of HIV KS in developing countries thus remains unanswered. The authors concluded that therapies discussed in the review are unlikely to be available or affordable in developing countries where the bulk of HIV infection and KS occur, apart from radiotherapy at a few tertiary centers. However, recent changes in pricing due to the global alliance and access initiatives mean that HAART is likely to be more available and accessible to developing countries in the near future. South Africa now has committed to this at cabinet level and had a task force to address this issue. HAART has been proposed as therapy for HIV KS on the basis of restoring immune competence and minimizing the HIV tat drive to KS formation. It also improves immunologic control of HHV 8 possibly through interrupting the HIV-1- HHV-8 interaction. There has been only one randomised trial conducted in Spain which compared HAART to the combination of HAART and CXT. There is to date no prospective, randomised controlled trial which compares the efficacy of HAART to the standard of care in HIV KS in Africa.

Study Details

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 26, 2006
Enrollment StartJan 1, 2003
Primary CompletionFeb 1, 2009
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 19.8 years ago

Interventions

Generic HAART Triomune : d4T, 3TC, NVPdrug

Triomune® (Cipla, Mumbai) Stavudine 40mg b.d \> 60 kg , 30mg bd \<60kg Lamivudine 150mg b.d \> 50 kg 2mg/kg \< 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks)

Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABVdrug

Triomune® (Cipla, Mumbai) Stavudine 40mg b.d \> 60 kg , 30mg bd \<60kg Lamivudine 150mg b.d \> 50 kg 2mg/kg \< 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks) Intramuscular Bleomycin 10 U/m2 ; Intravenous Vincristine 1.4mg/m2 maximum 2mg and Intravenous Doxorubicin 20mg/m2.