Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Chloroquine · 1 trial · 1 indication
A participant was considered to have demonstrated recurrence-free efficacy at 6 months if: a) Participant had non-zero P vivax asexual parasite count at Baseline. b) Participant showed initial clearance of P vivax parasitemia defined as two negative asexual P vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval. c) Participant had no positive asexual P vivax parasite count at any assessment prior to or on Study Day 201 following initial parasite clearance. d) Participant did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment. e) Participant is parasite-free at 6 months. Participants were censored if they did not have P.vivax at Baseline, or took a drug with anti-malarial action despite not having malaria parasites, or did not have a 6 month assessment. The number of participants with recurrence-free efficacy at 6 months has been summarized.
| Arm | Type | Description |
|---|---|---|
| Tafenoquine 50mg | EXPERIMENTAL | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 50mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed. |
| Tafenoquine 100mg | EXPERIMENTAL | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 100mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed. |
| Tafenoquine 300mg | EXPERIMENTAL | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 300mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed. |
| Tafenoquine 600mg | EXPERIMENTAL | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 600mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed. |
| Primaquine 15mg | ACTIVE_COMPARATOR | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 15mg Primaquine once daily Days 2-15. |
| Chloroquine only | PLACEBO_COMPARATOR | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. |
| Tafenoquine 300mg (Part 2) | EXPERIMENTAL | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 300mg Tafenoquine will be administered on either Day 1 or Day2 depending on when eligibility is confirmed. |
| Primaquine 15mg (Part 2) | ACTIVE_COMPARATOR | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered. 15mg Primaquine once daily Days 2-15 |
| Chloroquine only (Part 2) | PLACEBO_COMPARATOR | On Day 1 and Day 2 600mg Chloroquine will be administered, on Day 3 300mg Chloroquine will be administered |
| Name | Type | Description |
|---|---|---|
| Chloroquine 600mg | DRUG | 600mg Chloroquine given to each subject on Day 1 and Day2 of the trial |
| Chloroquine 300mg | DRUG | 300mg Chloroquine given to each subject on Day 3 of the trial |
| Tafenoquine 50mg | DRUG | single dose 50mg Tafenoquine given to subject on treatment arm 1 on Days 1 or 2 |
| Tafenoquine 100mg | DRUG | single dose 100mg Tafenoquine given to subject on treatment arm 2 on Days 1 or 2 |
| Tafenoquine 300mg | DRUG | single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2 |
| Tafenoquine 600mg | DRUG | single dose 600mg Tafenoquine given to subject on treatment arm 4 on Days 1 or 2 |
| Primaquine 15mg | DRUG | 15mg Primaquine given once daily to subject on treatment arm 5 on Days 2 to 15. |
| Chloroquine 600mg (Part 2 ) | DRUG | 600mg Chloroquine given to each subject on Day 1 and Day2 of the trial. |
| Chloroquine 300mg (Part 2 ) | DRUG | 300mg Chloroquine given to each subject on Day 3 of the trial. |
| Tafenoquine 300mg (Part 2) | DRUG | single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2. |
| Primaquine 15mg (Part2 ) | DRUG | 15mg Primaquine given once daily to subject on treatment arm 3 on Days 2 to 15. |
Inclusion Criteria: - Positive Giemsa smear for P. vivax * Parasite density \>100 and \<200,000/μL * ≥16 years * A female is eligible if she is non-pregnant, nonlactating and if she is of: - non-child bearing potential defined as: post-menopausal (12 months of spontaneous amenorrhea or 6 months of ...
Chloroquine is used for malaria, including Plasmodium vivax malaria. It is being studied in combination with tafenoquine for the prevention of vivax relapse. Chloroquine is a small molecule developed by GSK plc for the infectious disease area.
Chloroquine targets the malaria parasite in red blood cells. It interferes with the parasite's ability to break down and detoxify heme, a byproduct of hemoglobin digestion, leading to toxic accumulation and parasite death. This mechanism is effective against blood-stage malaria parasites.
GSK plc (ticker: GSK) is developing Chloroquine. The company is conducting clinical trials to evaluate Chloroquine in combination with tafenoquine for malaria treatment and relapse prevention.
Chloroquine is in Phase 2 clinical development for malaria. It is an investigational drug in this context, though it has a long history of use. The Phase 2 trial, NCT01376167, is completed and evaluated tafenoquine plus chloroquine for preventing vivax relapse.
Chloroquine is associated with three completed trials: NCT00871156, a Phase 1 drug-drug interaction study with tafenoquine in healthy volunteers; NCT01205178, a Phase 1 G6PD study evaluating hemolysis potential; and NCT01376167, a Phase 2b/3 study in vivax malaria relapse prevention. Total enrollment across trials was 851 participants.
No, Chloroquine is not the same as tafenoquine. They are different drugs studied in combination. Chloroquine is a 4-aminoquinoline antimalarial, while tafenoquine is an 8-aminoquinoline. In clinical trials, they are used together to prevent relapse of Plasmodium vivax malaria.