Comparative Evaluation of the Safety and the Efficacy of 2 Antimalarials Depending on HIV Status
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00304980 |
Recruitment Status
:
Terminated
First Posted
: March 21, 2006
Last Update Posted
: September 14, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Plasmodium Falciparum Malaria | Drug: ARTEMETHER + LUMEFANTRINE VS. SULFADOXINE + PYRIMETHAMINE | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 3000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparative Evaluation of the Safety and the Efficacy of Artemether + Lumefantrine (Coartem™) vs. Sulfadoxine + Pyrimethamine (SP) in Both HIV+ and HIV- Adults With Uncomplicated P. Falciparum Malaria in Zambia |
Study Start Date : | March 2003 |
Study Completion Date : | April 2005 |
- PCR corrected clinical and parasitological outcome at day 45
- Tolerability
- Clinical recovery

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Man and non-pregnant women aged between 15 and 50.
- P.falciparum mono-infection of at least 1,000 parasites/µl.
- Body temperature ≥ 37.5°C at the moment of enrolment or history of fever in the preceding 48 hrs.
- Consent from patient obtained.
Exclusion Criteria:
- Pregnancy.
- Severe P. falciparum malaria .
- Documented intake of SP or Coartem two weeks or less prior recruitment.
- Other cause(s) of fever.
- Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition).
- History of allergy to study drug, or known allergy to other Sulphur drugs such as co-trimoxazol.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304980
Zambia | |
Tropical Disease Research Center | |
Ndola, Cupperbelt, Zambia |
Principal Investigator: | Umberto D'Alessandro, MD,MSc, PHD | Institute of Tropical Medicine, Antwerp |
Publications of Results:
ClinicalTrials.gov Identifier: | NCT00304980 History of Changes |
Other Study ID Numbers: |
02 52 5 406 |
First Posted: | March 21, 2006 Key Record Dates |
Last Update Posted: | September 14, 2010 |
Last Verified: | September 2010 |
Additional relevant MeSH terms:
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Lumefantrine Artemether Pyrimethamine Sulfadoxine Artemether-lumefantrine combination Artemisinins Fanasil, pyrimethamine drug combination Antimalarials Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Antifungal Agents Coccidiostats Schistosomicides Antiplatyhelmintic Agents Anthelmintics Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |