Document Detail


A randomized controlled trial of highly active antiretroviral therapy versus highly active antiretroviral therapy and chemotherapy in therapy-naive patients with HIV-associated Kaposi sarcoma in South Africa.
MedLine Citation:
PMID:  22395672     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The optimal approach to HIV-associated Kaposi sarcoma (HIV-KS) in sub-Saharan Africa is unknown. With large-scale rollout of highly active antiretroviral therapy (HAART) in South Africa, we hypothesized that survival in HIV-KS would improve and administration of chemotherapy in addition to HAART would be feasible and improve KS-specific outcomes.
METHODS: We conducted a randomized, controlled, open-label trial with intention-to-treat analysis. Treatment-naive patients from King Edward VIII Hospital, Durban, South Africa, a public-sector tertiary referral center, with HIV-KS, but no symptomatic visceral disease or fungating lesions requiring urgent chemotherapy, were randomized to HAART alone or HAART and chemotherapy (CXT). HAART arm received stavudine, lamivudine, and nevirapine (Triomune; CXT arm received Triomune plus bleomycin, doxorubicin, and vincristine every 3 weeks. When bleomycin, doxorubicin, and vincristine were not available, oral etoposide (50-100 mg for 1-21 days of a 28-day cycle) was substituted. Primary outcome was overall KS response using AIDS Clinical Trial Group criteria 12 months after HAART initiation. Secondary comparisons included time to response, progression-free survival, overall survival, adverse events, HIV control, CD4 reconstitution, adherence, and quality of life.
RESULTS: Fifty-nine subjects were randomized to HAART and 53 to CXT; 12-month overall KS response was 39% in the HAART arm and 66% in the CXT arm (difference, 27%; 95% confidence interval, 9%-43%; P = 0.005). At 12 months, 77% were alive (no survival difference between arms; P = 0.49), 82% had HIV viral load <50 copies per milliliter without difference between the arms (P = 0.47); CD4 counts and quality-of-life measures improved in all patients.
CONCLUSIONS: HAART with chemotherapy produced higher overall KS response over 12 months, whereas HAART alone provided similar improvement in survival and select measures of morbidity. In Africa, with high prevalence of HIV and human herpes virus-8 and limited resources, HAART alone provides important benefit in patients with HIV-KS.
Authors:
Anisa Mosam; Fahmida Shaik; Thomas S Uldrick; Tonya Esterhuizen; Gerald H Friedland; David T Scadden; Jamila Aboobaker; Hoosen M Coovadia
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  60     ISSN:  1944-7884     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-05-25     Completed Date:  2012-07-25     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  150-7     Citation Subset:  IM; X    
Affiliation:
Department of Dermatology, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa. mosama@ukzn.ac.za
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-HIV Agents / administration & dosage*
Antigens, Neoplasm
Antiretroviral Therapy, Highly Active / methods*
Drug Therapy / methods*
Female
Humans
Lamivudine / administration & dosage
Male
Nevirapine / administration & dosage
Sarcoma, Kaposi / drug therapy*
South Africa
Stavudine / administration & dosage
Survival Analysis
Treatment Outcome
Grant Support
ID/Acronym/Agency:
D43 TW000231/TW/FIC NIH HHS; D43 TW000231-13/TW/FIC NIH HHS; D43TW00231/TW/FIC NIH HHS
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Antigens, Neoplasm; 0/SAGE protein, human; 129618-40-2/Nevirapine; 134678-17-4/Lamivudine; 3056-17-5/Stavudine
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