AEGiS-15IAC: Management of HIV Kaposi's sarcoma in South Africa: a prospective, randomised, open-labelled trial comparing the response to HAART with the combination of HAART and chemotherapy (CXT) Preliminary results of 32 patients.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Management of HIV Kaposi's sarcoma in South Africa: a prospective, randomised, open-labelled trial comparing the response to HAART with the combination of HAART and chemotherapy (CXT) Preliminary results of 32 patients.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. B10019)

Mosam A, Coovadia HM, Cassol S, Friedland GH, Scadden DT, Cassol E, Page T, Bodasing U, Dawood H, Aboobaker J, Jordaan JP, Lalloo UG
Nelson R Mandela, Durban, South Africa

BACKGROUND: HAART has decreased the incidence of Kaposi's sarcoma (KS) in the West and has been successful as therapy in isolated reports. There are no prospective trials on HAART as KS therapy. OBJECTIVE: 1. To document the clinical response of HIV KS to HAART (d4T, 3TC, NVP Arm 1) compared to the standard of care: combination of HAART and CXT (Arm 2 ) 2. To monitor and compare toxicity, CD4 and HIV 1 viral loads in response to each regimen.

METHODS: A prospective, randomised trial of 120 projected patients with HIV KS. Patients were staged,had CD4+counts, HIV-1 viral load and HHV 8. Five cutaneous indicator lesions of KS were selected and measured and response categorised as complete response (CR) partial response (PR), no response (NR) or disease progression (DP).

RESULTS: As at January 2004, 32 patients were recruited of 75 screened, 22 male and 10 female. Mean age was 35,4years (28-49yrs) and ethnic distribution was 31 Black (HIV-1Clade C), 1 White( HIV 1Clade B). Eighteen had good risk and 14 poor risk disease. Thirteen were randomized to HAART alone and 19 to HAART and CXT. Mean baseline CD4 was 204(1-523) cells/mm³ and viral load 161 742(5.2 log), range 4700-1 100 000. Twenty three ( 71.8%) reached undetectable viral loads(< 50 copies/ml). Of these,2( 8.7%) were undetectable by day 14, 4(26.1%) by day 28, 9(65.2%) by month 2 and 7(95.6%) by month 3. Patients on HAART had an early increase in CD4+ cells, while patients on combination therapy exhibited a decline followed by a gradual increase beginning at day 60. >Mean Clinical response was: CR in 5(1 on Arm 1, 4 on Arm 2), PR in 9( 2 on Arm 1, 7 on Arm 2), DP in 2( both on Arm 1, 1 with virological failure), 4 ( 2 on Arm 1 and 2 on Arm 2) deaths and 1 lost to follow up.

CONCLUSION: These preliminary findings indicate that rapid, effective clearance of HIV-1 can be achieved in late-stage HIV-1 KS, even with concomitant CXT. The combination arm is associated with a blunted CD4 response however it seems to provide a more favourable early clinical response.

Keywords: AEGIS, Antiretroviral Therapy, Highly Active, Acquired Immunodeficiency Syndrome, Sarcoma, Kaposi, HIV Seropositivity, CD4 Lymphocyte Count, Viral Load, HIV-1, Herpesvirus 8, Human, Stavudine, Drug Therapy, Combination, Lamivudine, Disease Progression, Incidence, CD4-Positive T-Lymphocytes, South Africa, Female, Male, Humans, drug therapy, organization & administration

040711
B10019