Trial · NCT01650558

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

NCT01650558, Not applicable, Completed, University of Maryland, Baltimore; results first posted 2021-05-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi. Trials, record NCT01650558. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01650558

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi
NCT number: NCT01650558
Status: Completed
Phases: Not applicable
Enrollment: 1,499 participants, actual
Lead sponsor: University of Maryland, Baltimore
Conditions: HIV
Interventions: Standard of Care prophylaxis, Chloroquine (CQ) prophylaxis
First posted: 2012-07-26
Last updated: 2022-07-28
Results first posted: 2021-05-19

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Severe Events	22-66 months	Incidence of severe events (composite of death and WHO stage 3 and 4 illness)
Secondary	Number of Participants With at Least One Detectable HIV Viral Load	Throughout study participation, measured every six months (2-5.5 years).	Number of participants who ever have a detectable viral load (\>400 copies/ml).
Secondary	CD4 Cell Count	Every 6 months for 22-66 months	Number of Participants with at Least One CD4 Count \<200
Secondary	WHO HIV Stage 2, 3, 4 Illness	32-66 months	Incidence of any WHO HIV stage 2, 3, or 4 illness
Secondary	Bacterial Infections and Malaria	32-66 months	Incidence of bacterial infections and malaria
Secondary	Adverse Events Greater Than or Equal to Grade 3 That Are Related to the Study Product	32-66 months	Occurrence of adverse events that are greater than or equal to Grade 3 that require discontinuation of TS or CQ prophylaxis
Other	Bacterial or Malaria Infection With CQ or TS Resistant Organism	32-66 months	Occurrence of bacterial or malaria infection with CQ or TS resistant organism
Other	Clinical and Parasitological Response to Antimalarial Therapy	32-66 months	Clinical and parasitological response to antimalarial therapy in cases of uncomplicated malaria

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Severe Events	22-66 months	Events per 100 participant-years	NUMBER
SECONDARY	Number of Participants With at Least One Detectable HIV Viral Load	Throughout study participation, measured every six months (2-5.5 years).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	CD4 Cell Count	Every 6 months for 22-66 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	WHO HIV Stage 2, 3, 4 Illness	32-66 months	Events per 100 participant-years	NUMBER
SECONDARY	Bacterial Infections and Malaria	32-66 months	Events per 100 participant-years	NUMBER
SECONDARY	Adverse Events Greater Than or Equal to Grade 3 That Are Related to the Study Product	32-66 months	Events per 100 participant-years	NUMBER
OTHER_PRE_SPECIFIED	Bacterial or Malaria Infection With CQ or TS Resistant Organism	32-66 months
OTHER_PRE_SPECIFIED	Clinical and Parasitological Response to Antimalarial Therapy	32-66 months

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Severe Events	Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis	3.3	Events per 100 participant-years
Severe Events	Chloroquine (CQ) Prophylaxis	4.2	Events per 100 participant-years
Severe Events	Discontinuation of Standard of Care (Control Arm)	4.2	Events per 100 participant-years
Number of Participants With at Least One Detectable HIV Viral Load	Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis	24	Participants
Number of Participants With at Least One Detectable HIV Viral Load	Chloroquine (CQ) Prophylaxis	36	Participants
Number of Participants With at Least One Detectable HIV Viral Load	Discontinuation of Standard of Care (Control Arm)	33	Participants
CD4 Cell Count	Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis	24	Participants
CD4 Cell Count	Chloroquine (CQ) Prophylaxis	23	Participants
CD4 Cell Count	Discontinuation of Standard of Care (Control Arm)	27	Participants
WHO HIV Stage 2, 3, 4 Illness	Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis	4.0	Events per 100 participant-years

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis	500
Overall Study	STARTED	Chloroquine (CQ) Prophylaxis	500
Overall Study	STARTED	Discontinuation of Standard of Care (Control Arm)	499
Overall Study	COMPLETED	Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis	417
Overall Study	COMPLETED	Chloroquine (CQ) Prophylaxis	408
Overall Study	COMPLETED	Discontinuation of Standard of Care (Control Arm)	424
Overall Study	NOT COMPLETED	Standard of Care Trimethoprim Sulfamethoxazol (TS) Prophylaxis	83
Overall Study	NOT COMPLETED	Chloroquine (CQ) Prophylaxis	92
Overall Study	NOT COMPLETED	Discontinuation of Standard of Care (Control Arm)	75

Source ClinicalTrials.gov

Adverse events132

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Infections	Infections and infestations	Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis	414	500
other	Infections	Infections and infestations	Chloroquine (CQ) Prophylaxis	428	500
other	Infections	Infections and infestations	Discontinuation of Standard of Care (Control Arm)	443	499
other	General	General disorders	Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis	304	500
other	General	General disorders	Chloroquine (CQ) Prophylaxis	267	500
other	General	General disorders	Discontinuation of Standard of Care (Control Arm)	312	499
other	Investigations	Investigations	Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis	298	500
other	Investigations	Investigations	Chloroquine (CQ) Prophylaxis	307	500
other	Investigations	Investigations	Discontinuation of Standard of Care (Control Arm)	278	499
other	Gastrointestinal	Gastrointestinal disorders	Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis	248	500

1 to 10 of 132Source ClinicalTrials.gov

See all 132 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis	10	500
Total, all-cause mortality	Chloroquine (CQ) Prophylaxis	6	500
Total, all-cause mortality	Discontinuation of Standard of Care (Control Arm)	8	499
Total, other adverse events	Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis	488	500
Total, other adverse events	Chloroquine (CQ) Prophylaxis	483	500
Total, other adverse events	Discontinuation of Standard of Care (Control Arm)	488	499
Total, serious adverse events	Standard of Care Trimethoprim Sulfamethoxazo (TS) Prophylaxis	72	500
Total, serious adverse events	Chloroquine (CQ) Prophylaxis	99	500
Total, serious adverse events	Discontinuation of Standard of Care (Control Arm)	116	499

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27431995	DERIVED	PubMed
33744963	BACKGROUND	PubMed
35848575	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AI089342	Clinical trial of trimethoprim-sulfamethoxazole or chloroquine in adults on ART	LAUFER, MIRIAM K.	UNIVERSITY OF MARYLAND BALTIMORE	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2011 to 2017

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01650558

GET https://conductscience.org/api/trials/v1/NCT01650558/events?page=2

API reference For AI assistants