A RANDOMIZED EVALUATION OF ANTIRETROVIRAL THERAPY ALONE OR WITH DELAYED CHEMOTHERAPY VERSUS ANTIRETROVIRAL THERAPY WITH IMMEDIATE ADJUNCTIVE CHEMOTHERAPY FOR TREATMENT OF LIMITED STAGE AIDS-KS IN RESOURCE-LIMITED SETTINGS (REACT-KS)

Not Applicable

• Registration Number: PER-081-11
• Lead Sponsor: INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-26
• Study Completion: 2018-02-20
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified