Tuberculosis Clinical Trial
Official title:
Early vs Late Introduction of Antiretroviral Therapy in Naive HIV-infected Patients With Tuberculosis in Cambodia
In Cambodia the prevalence of both tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
infection is high. Data suggest that aggressive management of HIV infection, which includes
Anti-Retroviral Therapy (HAART) during treatment of TB, decreases both morbidity and
mortality. On the other hand, the use of HAART for patients with TB may cause severe
complications due to drug-drug interactions, and occasionally a temporary exacerbation of
symptoms. These reactions may be particularly severe when HAART is started soon after the
start of TB treatment.
The proposed study aims to determine the optimal time to initiate HAART in previously
untreated HIV-infected adult patients with TB and low CD4 cell counts.
Status | Completed |
Enrollment | 661 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 or over - Positive HIV test result - CD4+ cell count under or equal to 200 cells per ml within 14 days prior the study entry - Positive AFB on any smear (sputum, lymph node drainage, stool, CSF, pleural fluid) - Naive to ART - TB treatment started less than one week prior enrolment - Negative gonadotrophin pregnancy test (blood) for women of childbearing potential (i.e. not surgically sterile or less than 2 years menopause) - Agreement from female candidates who are participating in sexual activity that could lead to pregnancy while receiving and for 6 weeks after stopping efavirenz to use two reliable methods of contraception, one of which including condom. Exclusion Criteria: - Suspected TB with negative AFB - Pregnant or breastfeeding women - Impaired hepatic function (icterus, elevated AST or ALT at least 5 times over the normal value) - Unable and/or unlikely to comprehend and/or be adherent to the protocol - Treated for a previous suspected or documented TB other than the ongoing infection which motivates enrolment in this trial |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Cambodia | Calmette Hospital | Phnom Penh | |
Cambodia | Khmero-Soviet Friendship Hospital | Phnom Penh | |
Cambodia | Siem Reap Referral Hospital | Siem Reap | |
Cambodia | Provincial hospital | Svay Rieng | |
Cambodia | Provincial hospital | Takeo |
Lead Sponsor | Collaborator |
---|---|
French National Agency for Research on AIDS and Viral Hepatitis | National Institutes of Health (NIH) |
Cambodia,
Blanc FX, Havlir DV, Onyebujoh PC, Thim S, Goldfeld AE, Delfraissy JF. Treatment strategies for HIV-infected patients with tuberculosis: ongoing and planned clinical trials. J Infect Dis. 2007 Aug 15;196 Suppl 1:S46-51. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival rate | At the end of the study | Yes | |
Secondary | Type, frequency and severity of Adverse Events that occur during the trial and to their potential relations with the drugs, HIV or TB infection | During the overall study | Yes | |
Secondary | Frequency of Immune Reconstitution Inflammatory Syndrome | During the overall study | Yes | |
Secondary | Frequency of TB paradoxical reaction, defined as worsening or emergence of signs or symptoms of TB (e.g. fever, cough, shortness of breath, adenopathy or exacerbation of disease at other extra pulmonary sites) during appropriate TB treatment | During the overall study | Yes | |
Secondary | Occurrence of opportunistic infections | During the overall study | No | |
Secondary | Evaluation of TB treatment success | During the overall study | No | |
Secondary | Evaluation of ART treatment success | During the overall study | No | |
Secondary | Resistance to ARV treatment determined by genotyping HIV-1 strains among patients with detectable viral load on Day 0 and Week 50 | Within 12 months of follow-up | No | |
Secondary | Patient's adherence to TB and ARV treatment evaluated based on interviews and pill counts at each study visit | During the overall study | No | |
Secondary | Pharmacokinetic study to assess efavirenz plasma exposure will be assayed at regular time intervals | Within 12 months of follow-up | No | |
Secondary | Survival Rate | 50 weeks after enrolment | Yes |
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