Prevention of Early Mortality by Presumptive Tuberculosis (TB) Treatment (PrOMPT)
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ClinicalTrials.gov Identifier: NCT01417988 |
Recruitment Status
:
Terminated
(Study was terminated prematurely due to insufficient enrolment.)
First Posted
: August 16, 2011
Last Update Posted
: February 17, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection Tuberculosis | Drug: Experimental: Empiric TB treatment Drug: ART only arm | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prevention of Early Mortality by Presumptive TB Treatment in HIV-infected Patients Initiating Antiretroviral Therapy |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Empiric TB treatment
Empiric initiation of 4 drug TB treatment (8 weeks of 4 drug, 16 weeks of 2 drug therapy) followed by ART (efavirenz-based) within 2 weeks
|
Drug: Experimental: Empiric TB treatment
Initiation of 4 drug TB treatment (8 weeks of 4 drug, 16 weeks of 2 drug therapy) followed by ART (efavirenz-based) within 2 weeks
|
Active Comparator: ART only arm
ART (efavirenz-based) only (+ pyridoxine 50mg) given within 2 weeks after enrolment
|
Drug: ART only arm
ART (efavirenz-based) only (+ pyridoxine 50mg) given within 2 weeks after enrolment
|
- All-cause mortality in the first 24 weeks after initiation of ART [ Time Frame: 24 weeks ]
- CD4 T cell absolute increase [ Time Frame: 24 weeks ]
- Causes of death [ Time Frame: 24 weeks ]
- Safety and tolerability of anti-tuberculous medications [ Time Frame: 24 weeks ]
- HIV viral suppression [ Time Frame: 24 weeks ]
- TB incidence rates after ART initiation [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged > 18 years old
- HIV-1 positive
- Eligible for antiretroviral treatment with CD4 T cell count < 50 cells/μl
- BMI < 18
Exclusion Criteria:
- Patients with smear-positive pulmonary TB
- Patients who fulfill the diagnostic criteria for smear-negative pulmonary or extrapulmonary TB (http://www.who.int/tb/publications/2006/tbhiv_recommendations.pdf ).
- Previous TB treatment (history of TB medication for > 1 month
- History of using antiretroviral drugs
- Symptomatic known underlying liver disease or transaminases > 5x upper limit of normal
- Known or suspected drug resistance to more than one first-line TB drug according to WHO criteria but excluding HIV infection (e.g. household contacts of MDRTB patients)
- Pregnant or breast-feeding
- Patients with cryptococcal meningitis (CrAG positive with neurologic symptoms)
- Patients with other severe (opportunistic) disease such as disseminated KS, malignant lymphoma, toxoplasmosis who may not be able to tolerate anti-TB medication or require other specific therapy
- Patients with danger signs (respiratory rate > 30 per minute, heart rate > 120bpm, temperature > 39oC, and unable to ambulate)
- Taking other potentially life-saving medications (e.g. for other OIs, or immunosuppressants) that are incompatible with anti-TB chemotherapy or ART
- Unable to swallow TB medications
- Unable to follow-up at the clinic for regularly scheduled follow-up (e.g. too far from clinic)

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): NCT01417988
Gabon | |
Medical Research Unit, Albert Schweitzer Hospital | |
Lambaréné, Gabon | |
Mozambique | |
Ministry of Health -Provincial Heatlh Directorate of the Sofala Province (Direcção Provincial de Saúde de Sofala DPSS) | |
Beira, Mozambique | |
Uganda | |
Infectious Diseases Institute University Makarere | |
Kampala, Uganda |
Study Director: | Frank Cobelens | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | |
Principal Investigator: | Yuka Manabe | Infectious Diseases Institute at Makerere University |
Additional Information:
Responsible Party: | Prof JMA Lange, Executive Scientific Director AIGHD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
ClinicalTrials.gov Identifier: | NCT01417988 History of Changes |
Other Study ID Numbers: |
AIGHD_001 |
First Posted: | August 16, 2011 Key Record Dates |
Last Update Posted: | February 17, 2014 |
Last Verified: | February 2014 |
Keywords provided by Prof JMA Lange, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
TB |
Additional relevant MeSH terms:
HIV Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
Efavirenz Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |