N/A N=1,499 Randomized Prevention

Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi

HIV

Bottom Line

View on ClinicalTrials.gov: NCT01650558 ↗

Enrolled (actual)

1,499

Serious AEs

19.2%

Results posted

May 2021

Primary outcome: Primary: Severe Events — 3.3; 4.2; 4.2 Events per 100 participant-years — p=<=0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Standard of Care prophylaxis (Drug); Chloroquine (CQ) prophylaxis (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Maryland, Baltimore
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Severe Events	3.3; 4.2; 4.2	<=0.05
SECONDARY Number of Participants With at Least One Detectable HIV Viral Load	24; 36; 33	<=0.05
SECONDARY CD4 Cell Count	24; 23; 27	<=0.05
SECONDARY WHO HIV Stage 2, 3, 4 Illness	4.0; 5.7; 5.8	<=0.05
SECONDARY Bacterial Infections and Malaria	27.8; 37.4; 36.3	<=0.05
SECONDARY Adverse Events Greater Than or Equal to Grade 3 That Are Related to the Study Product	0; 0.24; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Age 18 years or older
Documented HIV-1 infection
Initiation of ART through a government-sponsored ART program at least six months prior
Undetectable HIV viral load ( 250/mm3
TS prophylaxis prescribed for at least the previous 2 months
Intention to remain in the study area until the end of the study period
Informed consent from participant
Female study volunteers of reproductive potential must have a negative urine pregnancy test performed within 20 days before randomization.
Female study volunteers of reproductive potential who participate in sexual activity that could lead to pregnancy must use contraception (male or female condoms, diaphragm or cervical cap with spermicide, intrauterine device, or hormone-based contraceptive) while receiving their assigned study drug and for one month after stopping the medications.

Exclusion Criteria

Severe acute illness (defined as requiring hospitalization at the time of screening or other conditions such as laboratory abnormalities as determined by the investigators)
Chronic treatment (requiring therapy for > 14 days) or secondary prophylaxis (for toxoplasmosis, Pneumocystis pneumonia, or tuberculosis for example) with any drug with antimalarial or antibacterial activity
History of hypersensitivity to antifolate drugs or CQ
Laboratory exclusion criteria
Hemoglobin 210 U/L for men, >160 U/L for women
Serum creatinine concentration > 3.3mg/dl (291.7µmol/L) for men, and > 2.7mg/dl (238.7µmol/L) for women)
History of visual field or retinal changes
History of preexisting auditory damage
History of porphyria
History of psoriasis
History of liver disease
History of seizure disorder
History of glucose-6-phosphate dehydrogenase (G6PD) deficiency
History of ECG and cardiac conduction abnormality or cardiomyopathy
History of myopathy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01650558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.