Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT01650558
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 (\< 400 copies/mL)
* CD4 count \> 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 \< 8.0 gm/dL
* Platelet count \< 50,000/mm3
* Absolute granulocyte count \< 500/mm3
* Serum alanine aminotransferase (ALT) concentration \> 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01650558
Study Brief:
Protocol Section:
NCT01650558