Falciparum Parasitaemia Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled Evaluation of Weekly Tafenoquine (WR 238605/SB252263) Compared to Mefloquine for Chemosuppression of Plasmodium Falciparum in Western Kenya
This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of P. falciparum in Nyanza Province, western Kenya.
| Status | Completed |
| Enrollment | 306 |
| Est. completion date | March 2003 |
| Est. primary completion date | October 2000 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Healthy male or female volunteers who provided informed consent (a healthy volunteer was defined as one who was free of ailments that might cause difficulty in evaluating drug efficacy or adverse experiences). - Subjects aged 18-55 years. - Subjects planning to reside in the study area for the entire study duration of approximately 70 weeks Exclusion Criteria: - Subjects with positive parasitaemia following halofantrine treatment for radical cure. - Subjects with any medical condition which, in the opinion of the investigator, made the subject unsuitable to enter the study. - Subjects with personal or family history of seizures. - Female subjects with a positive serum beta-HCG5 (tested during screening and within 48 hours of first drug administration and approximately monthly thereafter). - Women who were pregnant or lactating or who in the opinion of the investigator were at risk of becoming pregnant. - Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and haematology values. Subjects who had demonstrated hypersensitivity to any of the study drugs especially to any other 8-aminoquinolines. - Subjects unwilling to report for drug administration or blood drawing during the 70 week duration of the study. - Subjects with G6PD deficiency. - Subjects with laboratory guideline values for exclusion: haemoglobin <10 gm/dL, platelets <80,000/mm3, WBC <3000ul3, creatinine or ALT more than twice the upper limit of normal for age. - Subjects with an abnormal ECG, particularly an extended QTc interval > 0.42 seconds. - Subjects taking any other anti-malarial product, or who had taken an antimalarial drug other than halofantrine within the previous two weeks. - Subjects who had received an investigational drug (a new chemical entity not registered for use) within 30 days or 5 half-lives whichever was the longer. - Subjects with a history of psychiatric disorder. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| U.S. Army Medical Research and Materiel Command | SmithKline Beecham |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prophylactic outcome defined by the subject having no positive smears. | 24 Weeks | No | |
| Secondary | Number of subjects with two consecutive positive smears. | 24 Weeks | No | |
| Secondary | Number of subjects with a single positive smear during the prophylactic treatment phase plus follow-up. | 28 Weeks | No | |
| Secondary | Number of subjects with two consecutive positive smears | 28 Weeks | No | |
| Secondary | Time to a single positive smear. | 28 Weeks | No | |
| Secondary | Time to two consecutive positive smears | 28 Weeks | No |