None listed
Conditions
Interventions
HIV-1 INFECTED MEN AND WOMEN ≥
18 YEARS OF AGE, WITH LIMITED-STAGE KS, WHO ARE CURRENTLY NOT RECEIVING ART AND ARE CHEMOTHERAPY AND RADIATION TREATMENT NAIVE MAY BE ENROLLED IN THIS STUDY. THE STUDY WILL COMPARE KS TUMOR OUTCOMES O
200 cells/mm³) AND ART (EXPERIENCED OR NAIVE) AND RANDOMIZED 1:1 TO ONE OF THE FOLLOWING ARMS IN STEP 1:
STEP 1:
ARM 1A: CO-FORMULATED EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE (EFV/
Sponsors
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 4.1.1 HIV-1 INFECTION, DOCUMENTED BY ANY LICENSED RAPID HIV TEST OR HIV ENZYME OR CHEMILUMINESCENCE IMMUNOASSAY (E/CIA) TEST KIT AT ANY TIME PRIOR TO STUDY ENTRY AS CONFIRMED BY A LICENSED WESTERN BLOT OR A SECOND ANTIBODY TEST BY A METHOD OTHER THAN THE INITIAL RAPID HIV AND/OR E/CIA OR BY HIV-1 ANTIGEN, PLASMA HIV-1 RNA VIRAL LOAD. NOTE: THE TERM LICENSED REFERS TO AN FDA- APPROVED KIT WHICH IS REQUIRED FOR ALL IND STUDIES, OR A KIT THAT HAS BEEN CERTIFIED OR LICENSED BY AN OVERSIGHT BODY WITHIN THAT COUNTRY AND VALIDATED INTERNALLY. NON-US SITES ARE ENCOURAGED TO USE FDA-APPROVED METHODS FOR IND STUDIES. WORLD HEALTH ORGANIZATION (WHO) AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) GUIDELINES MANDATE THAT CONFIRMATON OF THE INITIAL TEST RESULT MUST USE A TEST THAT IS DIFFERENT FROM THE ONE USED FOR THE INITIAL ASSESSMENT. A REACTIVE INITIAL RAPID TEST SHOULD BE CONFIRMED BY EITHER ANOTHER TYPE OF RAPID ASSAY OR AN E/CIA THAT IS BASED ON A DIFFERENT ANTIGEN PREPARATION AND/OR DIFFERENT TEST PRINCIPLE (eg., INDIRECT VERSUS COMPETITIVE), OR A PLASMA HIV-1 RNA VIRAL LOAD.
Exclusion criteria
Exclusion criteria: 4.2.1 ANY MANIFESTATION OF KS WHICH, IN THE OPINION OF THE SITE INVESTIGATOR, REQUIRES IMMEDIATE CHEMOTHERAPY. NOTE: A CHEST X-RAY MUST BE PERFORMED WITHIN 30 DAYS PRIOR TO STUDY ENTRY TO EVALUATE FOR PRESENCE OF PULMONARY KS, WHICH WOULD INDICATE T1 DISEASE AND GENERALLY REQUIRE CHEMOTHERAPY. 4.2.2 RECEIPT OF ART WITHIN 6 MONTHS PRIOR TO STUDY ENTRY. 4.2.3 BIOPSY PROVEN KS DURING PREVIOUS ART. 4.2.4.BREASTFEEDING 4.2.5 ALLERGY/SENSITIVITY TO ANY STUDY DRUG OR ITS FORMULATIONS. 4.2.6 ANY PRIOR SYSTEMIC ANTI-NEOPLASTIC TREATMENT FOR KS (INCLUDING CHEMOTHERAPY, BIOLOGICAL THERAPY, IMMUNOTHERAPY OF INVESTIGATIONAL THERAPY). 4.2.7 ANY PRIOR LOCAL TREATMENT OF CUTANEOUS MARKER LESIONS UNLESS THERE WAS EVIDENCE OF A CLEAR-CUT PROGRESSION OF THE LESION. 4.2.8 RECEIPT OF ANY INVESTIGATIONAL THERAPY WITHIN 30 DAYS PRIOR TO STUDY ENTRY. 4.2.9 CURRENT OR ANTICIPATED RECEIPT OF ANY OF THE PROHIBITED MEDICATIONS INDICATED IN THE PSWP. 4.2.10 IN THE OPINION OF THE SITE INVESTIGATOR, ANY PSYCHOLOGICAL OR SOCIAL CONDITION, OR ADDICTIVE DISORDER THAT WOULD PRECLUDE COMPLIANCE WITH THE PROTOCOL.
Countries
Brazil, Kenya, Malawi, Peru, South Africa, Uganda, Zimbabwe
Contacts
Public ContactFanny Garcia
ASOCIACION CIVIL IMPACTA, SALUD Y EDUCACION
Outcome results
None listed