HIV Infections Clinical Trial
Official title:
The Pharmacokinetics and Safety of Ritonavir-boosted Indinavir 600/100mg Bid Combined With NRTIs in ARV naïve HIV/TB Co-infected Patients Receiving Rifampicin Containing Anti-tuberculosis Therapy
Verified date | July 2020 |
Source | The HIV Netherlands Australia Thailand Research Collaboration |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK profile associated with adequate antiretroviral potency, tolerability and efficacy.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2009 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Confirmed HIV positive after voluntary counselling and testing - Aged between 18 and 60 years of age - Antiretroviral treatment naive - CD4+ cell count of <200 cells/mm3 at the time of TB diagnosis - ALT <5 times ULN - Serum creatinine <1.4 mg/dl - Haemoglobin >8 mg/L - TB diagnosis; either probable (clinical symptoms plus chest x-ray and response to anti-TB medication) or definitive( sputum AFB culture confirmed) and receiving or planning to receive rifampicin-containing anti-TB therapy for at least a 2 week period before the initiation of ART - No other active OI (CDC class C event) - Able to provide written informed consent Exclusion Criteria: - Current use of steroids and other immunosuppressive agents - Current use of any prohibited medications related to compliance and drug pharmacokinetics - Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial. - Previous exposure to nevirapine monotherapy - Unlikely to be able to remain in follow-up for the protocol defined period - Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST < 5 x ULN. - Karnofsky performance score <30% |
Country | Name | City | State |
---|---|---|---|
Thailand | HIV-NAT Thai Red Cross AIDS Research Center | Bangkok |
Lead Sponsor | Collaborator |
---|---|
The HIV Netherlands Australia Thailand Research Collaboration |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pharmacokinetics of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy. | 2 weeks | ||
Secondary | safety of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy | 48 weeks | ||
Secondary | efficacy of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy | 48 weeks | ||
Secondary | the prevalence of immune recovery syndrome of TB and other HIV-related conditions after ritonavir-boosted indinavir 600/100mg bid | 48 weeks |
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