HIV Infection Clinical Trial
— MACOMBAOfficial title:
Comparative Study of Efficacy of Two Antifolates Prophylactic Strategies Against Malaria in HIV Positive Pregnant Women (MACOMBA Study)
NCT number | NCT01746199 |
Other study ID # | 2012-03 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | December 2013 |
Est. completion date | December 2019 |
Verified date | November 2020 |
Source | Institut Pasteur |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Given the resistance emergence of malaria in pregnant women receiving intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP) and the burden of this infection among pregnant women infected by HIV it is urgent to seek a more effective alternative treatment to optimize the prevention of malaria. Cotrimoxazole (CTM), actually administered daily as a prophylactic mean to opportunistic infections for HIV infected patients, showed encouraging results in preventing malaria in pregnant women. However, these results must be confirmed by randomized trials, particularly in pregnant women. The main objective of this clinical trial is to compare the efficacy of cotrimoxazole (CTM), administered once daily with IPT-SP (3 curative doses spaced one month) on placental parasitaemia in pregnant women infected with HIV and cluster of differentiation 4 (CD4) > 350 cells/mm3. The main hypothesis is based on the premise that cotrimoxazole is more effective than IPT-SP for placental parasitaemia. This might be due to the higher plasma concentration of cotrimoxazole attained with daily doses. If this hypothesis is proven, cotrimoxazole could be recommended as prophylaxis for HIV-positive pregnant women, whatever their CD4+ cell count. In this study, the investigators will also test the hypothesis that the strains of Plasmodium falciparum isolated from HIV-positive pregnant women express more dhfr and dhps resistance markers.
Status | Completed |
Enrollment | 193 |
Est. completion date | December 2019 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age = 18 years - HIV positivity - gestational age between 16 and 28 weeks - CD4+ count > 350 cells/mm3 and no sign of WHO stage 2, 3 or 4; - agreement to attend all the antenatal consultations for the study - willingness to adhere to all requirements of the study (including HIV-1 voluntary counseling and testing) - signed informed consent Exclusion Criteria: - psychological instability that could interfere with compliance; - hypersensitivity to sulfamides or dermatological disease(eczema, pemphigoid exanthema) that would increase the risk for severe reactions to the drugs being tested - severe anaemia (Hb<7 g/dl)and any other severe disease - known hepatic cardiac or renal disease |
Country | Name | City | State |
---|---|---|---|
Central African Republic | Maternité de l'Hôpital communautaire | Bangui | |
Central African Republic | Maternité de l'Hôpital de l'Amitié | Bangui | |
Central African Republic | Maternité de la Gendarmerie Nationale | Bangui | |
Central African Republic | Maternité du centre de santé des Castors | Bangui |
Lead Sponsor | Collaborator |
---|---|
Institut Pasteur | Institut Pasteur de Bangui |
Central African Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | placental parasitaemia | microscopic observation and confirmation by Polymerase Chain Reaction (PCR) | at parturition | |
Secondary | observance CTM prophylaxis | until the end of pregnancy | ||
Secondary | occurrence of specific events related to the effectiveness of CTM prophylaxis and IPT-SP | considered events :
maternal anemia (hemoglobinemia < 10g/dl) incidence of malaria episodes during pregnancy abortions, stillbirth, premature (birth <37 weeks of amenorrhea) and low birth weight (< 2500g) placenta malaria and umbilical malaria transmission |
until the end of pregnancy | |
Secondary | occurence of adverse events | until the end of pregnancy |
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