CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,499 enrolled
Drug / intervention
Standard of Care prophylaxis +1 moredrug
Likely dose
Not stated in 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/NCT01650558
NCT01650558N/ACompleted

Randomized, Open-label Controlled Trial of Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on Anti-retroviral Therapy in Malawi

University of Maryland, Baltimore·interventional·Posted Jul 26, 2012·Updated Jul 28, 2022

In Brief

A clinical study evaluating Standard of Care prophylaxis and Chloroquine (CQ) prophylaxis for HIV. Completed, enrolled 1,499 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine if there is a benefit to taking trimethoprim-sulfamethoxazole (TS) as prophylaxis among HIV positive adults who have viral load suppression and a good clinical response on anti-retroviral therapy (ART). If there is a benefit, then is it due to antimalarial or antibacterial properties. The investigators hypothesize that there will be a long-term benefit on survival and disease control in the context of prophylaxis and that the benefit will largely be attributed to prevention of malaria. The main study hypothesis is that 1)TS and chloroquine (CQ) will decrease the rates of morbidity and mortality among adults after 6 or more months of ART and 2) CQ prophylaxis will be associated with more prolonged viral suppression and higher CD4 cell counts than TS prophylaxis or no prophylaxis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesMalawi

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2012
Enrollment StartNov 1, 2012
Primary CompletionJul 31, 2018
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 13.9 years ago

Interventions

Standard of Care prophylaxisdrug

Daily trimethoprim sulfamethoxazole

Chloroquine (CQ) prophylaxisdrug

Discontinue standard of care and start weekly CQ.