Completed Pregnancy, Children & Inherited Conditions Infection & Immunity

Safety of discontinuing Cotrimoxazole Prophylaxis among African adults on ART. A randomised controlled trial

In plain English

AI plain-English summary

In Uganda, doctors will test whether thousands of HIV patients on antiretroviral therapy can safely stop taking a daily antibiotic called cotrimoxazole without getting sick. This matters because cotrimoxazole prevents dangerous infections in people with damaged immune systems, and it is standard practice for HIV patients across Africa. But antiretroviral drugs now restore immune function in many patients, raising the question of whether the extra pill is still needed. Studies in wealthy countries showed it could be safely discontinued once immunity recovered, but no trials have proven this works in Africa, where patients face different infections and health system pressures. If the trial shows discontinuation is safe, the impact would be concrete and practical. Patients would take fewer pills each day, reducing side effects and the burden of lifelong treatment. Better adherence to antiretrovirals could follow, and health systems would save money on cotrimoxazole supplies. The study directly addresses a daily reality for thousands of people: whether a pill they have taken for years still benefits them.

View original technical description
Patients with HIV infection often have severe damage to the body?s immune system and are at risk of various other infections (so called opportunistic infections) that may cause disease and death. Daily intake of the antinfective medication: cotrimoxazole (CTX) has been shown to be highly effective in reducing the frequency of these infectious complications of HIV disease. This prophylactic treatment with cotrimoxazole has therefore become standard practice for HIV infected patients. In industrialised countries, after the introduction of antiretroviral (ARV) treatments for HIV infection, studies showed that the additional prophylaxis with cotrimoxazole could safely be discontinued once patients showed evidence of restoration of their immune function. For some years now, many HIV infected patients in Africa have also started to receive antiretroviral treatments. ARVs help to restore a person?s immune system (although they cannot cure a person from HIV infection) and the provision of ARVs has changed the health of thousands of HIV infected people and dramatically reduced the death rate among those who take them. It may also be possible to discontinue CTX prophylaxis among patients whose immune system is working well again, but no studies have demonstrated the safety of this practice in Africa. Since ARV treatment is lifelong, it would be desirable; in order to reduce pill burden, reduce the risk of possible treatment side effects and contribute to better ARV treatment adherence and reduction of treatment costs. The planned study in Uganda will address this important question among African patients by investigating whether patients who are responding well to ARV treatment can discontinue prophylactic treatment with CTX without a substantially higher risk of becoming ill.

View the original record at the funder ↗

Researchers

Heiner Grosskurth (Principal Investigator)Paula Munderi (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

Primary prevention of invasive cryptococcal disease using fluconazole prophylaxis in HIV infected Ugandans
Reduction of Early mortaLITY in HIV-infected African adults and children starting antiretroviral therapy: REALITY trial
Pragmatic use of long-acting Oral Antiretrovirals in Africa
A phase III randomised controlled trial of oral fluconazole plus flucytosine versus amphotericin B-based therapy for o
TB fast track: effect of a point-of-care TB test-and-treat algorithm on early mortality in people with HIV accessing ART

Original classification

Research Grant

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.