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Sponsors and Collaborators: |
MRC/UVRI Uganda Research Unit on Aids Medical Research Council |
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Information provided by: | MRC/UVRI Uganda Research Unit on Aids |
ClinicalTrials.gov Identifier: | NCT00674921 |
According to the national guidelines in Uganda and to the World Health Organization guidelines, HIV-infected patients should receive cotrimoxazole prophylaxis indefinitely. There are, however, concerns regarding the indefinite application of cotrimoxazole prophylaxis among patients immunologically stabilized on HAART (e.g. high pill burden, drug-drug interactions, toxicity and poor adherence because of treatment fatigue). To date no empirical evidence is available regarding the safety and optimal timing for the cessation of cotrimoxazole prophylaxis among HAART patients who successfully restored immunological competence.
Research question: Does morbidity significantly differ between continuation (orthodox) and cessation (experimental) of cotrimoxazole prophylaxis among immuno-competent patients stable HAART in the resource-limited setting of Uganda?
Condition | Intervention | Phase |
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HIV Infections |
Drug: cotrimoxazole Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Cotrimoxazole Prophylaxis Cessation Study Among Stabilized HIV-Infected Adult Patients on HAART in Entebbe, Uganda |
Estimated Enrollment: | 1650 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
It will comprise patients randomized to receive the placebo (stop cotrimoxazole prophylaxis) at CD4 counts of 200 or more but less than 350 cells/ul as they continue with HAART. Patients will be followed until they achieve a CD4 count of 350 cells/ul.
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Drug: Placebo
starch, magnesium stearate, sodium lauryl sulphate
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2: Active Comparator
It will comprise patients randomized to continue with cotrimoxazole prophylaxis and HAART at CD4 counts of 200 or more but less than 350 cells/ul. These patients will be followed until they achieve a CD4 count of 350 cells/ul and above, at which point they will be considered for the second randomization.
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Drug: cotrimoxazole
cotrimoxazole 800/160 mg once daily as indicated by the start and end times of the specified arms for continued prevention of HIV-related infections
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A: Placebo Comparator
This arm will comprise patients who have achieved a CD4 count of 350 or more cells/ul either at the beginning of the study or once they have reached this threshold at the end of follow up in arms 1 and 2. They (including those previously in Arm 1) will receive the placebo (stop cotrimoxazole prophylaxis) after the second randomization but continue with HAART.
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Drug: Placebo
starch, magnesium stearate, sodium lauryl sulphate
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B: Active Comparator
It will comprise patients randomized to continue or start with cotrimoxazole prophylaxis and HAART at CD4 of 350 or more cells/ul after second randomization. Some of them will have used cotrimoxazole prophylaxis whilst they were in arm 2 and others in arm 1 will restart cotrimoxazole prophylaxis at this stage.
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Drug: cotrimoxazole
cotrimoxazole 800/160 mg once daily as indicated by the start and end times of the specified arms for continued prevention of HIV-related infections
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Randomized double-blind placebo controlled equivalence trial to be conducted among consenting clinically healthy patients on HAART with 2 or more CD4 counts of 200 cells/ul or more for at least 3 months. The study will enable comparison of effects of randomized cessation of cotrimoxazole prophylaxis at 2 CD4-guided thresholds (200 Vs 350 cells/ul).
Rationale for inclusion of the placebo-controlled design
First randomisation
Patients who have been on HAART for at least 3 months and who have a confirmed CD4 count between 200 and 349 cells/ul will be randomized to continue prophylaxis with active cotrimoxazole or to cease prophylaxis with active cotrimoxazole but continue with ingestion of the placebo cotrimoxazole daily.
Second randomization
Patients who achieve a confirmed CD4 count of 350 cells/ul or more while on HAART will be randomized to continue prophylaxis with active cotrimoxazole or to cease prophylaxis with active cotrimoxazole but continue with ingestion of placebo cotrimoxazole daily. Some patients will have participated already in 1st randomization but others will be entering the trial at this stage for the first time.
Rationale for 4 trial arms
In order to assess the separate effects of cessation of cotrimoxazole prophylaxis in trial patients at the 2 randomization stages above, those continuing with prophylaxis will be compared with those ceasing prophylaxis, necessitating 2 arms at each stage.
Ages Eligible for Study: | 16 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: George Mukalazi Miiro, MSc, MBChB | 256-414-320-272 | george.miiro@mrcuganda.org |
Contact: Heiner Grosskurth, PhD, MD | 256-414-320-272 | heiner.grosskurth@mrcuganda.org |
Uganda | |
MRC/UVRI Uganda Research Unit on Aids | |
Entebbe, Uganda, 256 |
Principal Investigator: | George Miiro, MSc, MBChB | MRC/UVRI Unit |
Study Director: | Heiner Grosskurth, PhD, MD | MRC/UVRI Unit |
Principal Investigator: | Paula Munderi, MRCP, MBChB | MRC/UVRI Unit |
Responsible Party: | MRC/UVRI Uganda Research Unit on Aids ( Dr George Miiro ) |
Study ID Numbers: | 009/ESR/NDA/DID-01/2008 |
Study First Received: | May 6, 2008 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00674921 |
Health Authority: | Uganda: National Council for Science and Technology |
Opportunistic Infections AIDS HIV Treatment Experienced |
Virus Diseases Opportunistic Infections Trimethoprim Sexually Transmitted Diseases, Viral Sulfamethoxazole HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Trimethoprim-Sulfamethoxazole Combination Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Immune System Diseases Anti-Infective Agents, Urinary Infection |
Renal Agents Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Lentivirus Infections |