HIV InfectionsNCT00373048
Mefloquine Prophylaxis in HIV-1 Individuals: a Randomized Placebo-controlled Trial
A study testing mefloquine in people with HIV Infections, run by Institute of Tropical Medicine, Belgium at 1 site in Zambia.
Trial summary
This is a randomized placebo controlled trial. Malaria chemoprophylaxis with mefloquine in asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya, Zambia will be compared to a placebo control group and followed up for 18 months. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- mefloquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteZambia
- Study dates
- Oct 2005to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Permanent residents of the Luanshya district
- Males and non pregnant adults between 18 and 50 years old.
- Having a CD4 cell count of least 350 perµL at enrolment
- HIV sero-status determined at the VCT of the health center.
- No obvious underlying disease at time of enrolment
- Signed informed consent
Who cannot join
- HIV stage III or IV following the WHO classification (see attached documents regarding policy in Zambia)
- Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition, TB).
- Intent to move out of the study catchment area during the study period
- History of allergy to MQ (or related drugs) or sulfa drugs
- Chorionic gonadotrophic hormone in urine or obvious pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mefloquine Malaria Prophylaxis in HIV-1 Infected Individuals and Its Influence on the Evolution Towards AIDS: a Randomized Placebo-controlled Trial
This is a randomized placebo controlled trial. Malaria chemoprophylaxis with mefloquine in asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya, Zambia will be compared to a placebo control group and followed up for 18 months.
Read the detailed description
In Zambia prompt treatment of malaria cases is the mainstay of malaria control; antimalarial chemoprophylaxis is not currently recommended for general use so that the use of placebo as a comparator in this study is justified. We will analyse safety and efficacy of mefloquine, malaria and AIDS related parameters at predefined time points, and verify if this intervention could produce a slower decrease in CD4 counts compared to passive case management of malaria.
This is a randomized placebo controlled trial. Malaria chemoprophylaxis with mefloquine in asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya, Zambia will be compared to a placebo control group and followed up for 18 months.
Specific designed studies taking into account possible confounding parameters (and interactions) are needed to measure the impact of malaria control in an HIV endemic environment. In particular, the question should be answered if malaria control has an impact on the disease progression of HIV. The possible impact of these interventions on morbidity and mortality taking into account these parameters might have a major public health impact. This might be on the use of antiretroviral drugs, the incidence of clinical (eventually severe) malaria and spread of antimalarial resistance through immune compromised HIV patients (with and without antimalarial treatment).
Studies of alternative strategies that contribute (next to antiretrovirals) to the control and prevention of HIV pandemic are equally important and urgently needed. The need to design these strategies is critical given the high incidence of malaria and HIV in countries in Sub Saharan Africa such as Zambia and its serious impact on survival and the socio-economic situation. Moreover, a cost-benefit analysis might show that some alternative strategies have a major impact on the field with less technical, financial and social constraints than the strategies recommended so far.
All HIVP patients will be treated for opportunistic infections (OI) and receive antiretroviral drugs following the National guidelines on Management and Care of Patients with HIV/AIDS (also if this occurs after the study period). At the time they need cotrimoxazole prevention or/and receive antiretrovirals they would have reached a study endpoint and will be excluded from the trial though the follow up will continue.
- Conditions
- HIV Infections
- Being tested
- mefloquine, placebo
- Keywords
- HIV-1 malaria Clinical Trial
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mefloquineDrug
tablet, once weekly
placeboDrug
tablet, once weekly
| Study group | Role | What they receive |
|---|---|---|
| Placebo, tablet | Placebo comparator | Not described Receives: Drug: placebo |
| mefloquine, tablet | Experimental | Not described Receives: Drug: mefloquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of decline of CD4 counts between different time points
Measured: months 0, 6, 12 and 18
Proportion of patients entering the AIDS stage (WHO stage 3,4)
Measured: during 18 months
Secondary outcomes (7)
Mean difference in log plasma viral load at different time points,
Measured: during 18 months
Rate of decline of humoral immunity between different time points.
Measured: during 18 months
Proportion of patients with parasitaemia at the end of the intervention.
Measured: during 18 months
All cause disease incidence and prevalence (including malaria, TB)
Measured: during 18 months
Proportion of patients with Adverse event during monitoring
Measured: during 18 months
Prevalence of anaemia at different time points
Measured: during 18 months
Incidence of severe anaemia
Measured: during 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startOct 2005
- Primary completionDec 2007
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Investigators
- Umberto D'Alessandro, MD,MSc, PHD, Study director, Institute of Tropical Medicine Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373048
- Sponsor's protocol ID
- Mefloquine HIV zambia
- Status last verified
- May 2011
- First submitted
- 5 Sep 2006
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mefloquine Malaria Prophylaxis in HIV-1 Infected Individuals and Its Influence on the Evolution Towards AIDS: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00373048
- Acronym / sponsor ID
- Mefloquine HIV zambia
- Conditions
- HIV Infections
- Keywords
- HIV-1 malaria Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized placebo controlled trial. Malaria chemoprophylaxis with mefloquine in asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya, Zambia will be compared to a placebo control group and followed up for 18 months.
Detailed description
In Zambia prompt treatment of malaria cases is the mainstay of malaria control; antimalarial chemoprophylaxis is not currently recommended for general use so that the use of placebo as a comparator in this study is justified. We will analyse safety and efficacy of mefloquine, malaria and AIDS related parameters at predefined time points, and verify if this intervention could produce a slower decrease in CD4 counts compared to passive case management of malaria.
This is a randomized placebo controlled trial. Malaria chemoprophylaxis with mefloquine in asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya, Zambia will be compared to a placebo control group and followed up for 18 months.
Specific designed studies taking into account possible confounding parameters (and interactions) are needed to measure the impact of malaria control in an HIV endemic environment. In particular, the question should be answered if malaria control has an impact on the disease progression of HIV. The possible impact of these interventions on morbidity and mortality taking into account these parameters might have a major public health impact. This might be on the use of antiretroviral drugs, the incidence of clinical (eventually severe) malaria and spread of antimalarial resistance through immune compromised HIV patients (with and without antimalarial treatment).
Studies of alternative strategies that contribute (next to antiretrovirals) to the control and prevention of HIV pandemic are equally important and urgently needed. The need to design these strategies is critical given the high incidence of malaria and HIV in countries in Sub Saharan Africa such as Zambia and its serious impact on survival and the socio-economic situation. Moreover, a cost-benefit analysis might show that some alternative strategies have a major impact on the field with less technical, financial and social constraints than the strategies recommended so far.
All HIVP patients will be treated for opportunistic infections (OI) and receive antiretroviral drugs following the National guidelines on Management and Care of Patients with HIV/AIDS (also if this occurs after the study period). At the time they need cotrimoxazole prevention or/and receive antiretrovirals they would have reached a study endpoint and will be excluded from the trial though the follow up will continue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo, tablet | Placebo comparator | Drug: placebo |
| mefloquine, tablet | Experimental | Drug: mefloquine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Permanent residents of the Luanshya district
- Males and non pregnant adults between 18 and 50 years old.
- Having a CD4 cell count of least 350 perµL at enrolment
- HIV sero-status determined at the VCT of the health center.
- No obvious underlying disease at time of enrolment
Key exclusion criteria (5 listed)
- HIV stage III or IV following the WHO classification (see attached documents regarding policy in Zambia)
- Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition, TB).
- Intent to move out of the study catchment area during the study period
- History of allergy to MQ (or related drugs) or sulfa drugs
- Chorionic gonadotrophic hormone in urine or obvious pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mefloquinetablet, once weekly | Drug | mefloquine, tablet |
| placebotablet, once weekly | Drug | Placebo, tablet |
Primary outcome
Rate of decline of CD4 counts between different time points
Time frame: months 0, 6, 12 and 18
Proportion of patients entering the AIDS stage (WHO stage 3,4)
Time frame: during 18 months
7 secondary outcomes
Mean difference in log plasma viral load at different time points,
Time frame: during 18 months
Rate of decline of humoral immunity between different time points.
Time frame: during 18 months
Proportion of patients with parasitaemia at the end of the intervention.
Time frame: during 18 months
All cause disease incidence and prevalence (including malaria, TB)
Time frame: during 18 months
Proportion of patients with Adverse event during monitoring
Time frame: during 18 months
Prevalence of anaemia at different time points
Time frame: during 18 months
Incidence of severe anaemia
Time frame: during 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umberto D'Alessandro, MD,MSc, PHD study director
Institute of Tropical Medicine Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mefloquine in people with HIV Infections, run by Institute of Tropical Medicine, Belgium at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of decline of CD4 counts between different time points (time frame: months 0, 6, 12 and 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2011.