Phase 2
N=66
Studies of a Candidate Aminoquinoline Antimalarial (AQ-13)
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT01614964 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Cure Rates of AQ-13 and Coartem for Uncomplicated Plasmodium Falciparum Malaria in Adult Malian Males. — 28; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AQ-13 Treatment (Drug); Coartem Treatment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Tulane University
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rates of AQ-13 and Coartem for Uncomplicated Plasmodium Falciparum Malaria in Adult Malian Males. |
28; 31 | — |
| SECONDARY Number of Participants With Adverse Events |
32; 33; 0; 0 | — |
| SECONDARY Parasite Clearance Time |
47.3; 32.5 | — |
| SECONDARY Number of Participants With Recrudescence of Infection |
0; 2 | — |
| SECONDARY QTc Interval Response Following Antimalarial Treatment |
-1.2; 0.4 | — |
| SECONDARY Mean Fever Clearance Time in Days |
1.0; 1.23 | — |
| SECONDARY Peak Cmax |
2.526 | — |
| SECONDARY Time to Peak Tmax |
28.1 | — |
| SECONDARY 1-week AUC |
205.4 | — |
| SECONDARY Mean Residence Time |
7.19 | — |
| SECONDARY Clearance |
5.86 | — |
| SECONDARY Elimination t½ |
3.85 | — |
Summary
This is an initial efficacy study of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment, which is 2 doses of Coartem twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites. Funding Source - FDA Office of Orphan Product Development (OOPD).
Eligibility Criteria
Inclusion Criteria
- Adult Malian males ≥ 18 years of age,
- Uncomplicated malaria with ≥ 2, 000 asexual P. falciparum parasites per ul, and
- Informed consent obtained and signed.
Exclusion Criteria
- Severe or complicated malaria (including temperature ≥ 40o C),
- ≥ 100, 000 asexual parasites per ul of blood,
- Anemia or other laboratory results (other than malaria) that require treatment (e.g., Hb ≤ 7 gm/dL, K+ ≤ 3.5 millimolar (mM), BP ≥ 140/90),
- Seizures or impaired consciousness,
- Recent antimalarial treatment by history (within ≤ 2 weeks),
- Chronic medications (including inducers of Cytochrome P450 3A4 [CYP3A4] activity such as rifampin and nevirapine),
- Ventricular or atrial arrhythmias, or second or third degree heart block on the screening ECG or Holter recording,
- Infection with other plasmodial species on the blood smear (P. ovale, P. ovale, P. vivax).
Data sourced from ClinicalTrials.gov (NCT01614964). 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.