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Sponsored by: |
The HIV Netherlands Australia Thailand Research Collaboration |
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Information provided by: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT00411996 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Tuberculosis |
Drug: indinavir/ritonavir |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
IDV/r 600/100 mg + rifampicin
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Drug: indinavir/ritonavir
IDV/r 600/100 mg BID + rifampicin OD for at least 2 weeks
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The fixed-dose combination of d4T+3TC+NVP (GPOvir) has been widely used in Thailand since June 2002. The prevalence of NNRTI resistance has increased since 2005. Efavirenz-based antiretroviral therapy (ART) is preferred in patients with TB/HIV receiving rifampin-containing TB regimens. However, efavirenz cannot be used in the context of NNRTI failure, intolerance or toxicity. The optimal ART in populations receiving rifampicin remains unknown.
Rifabutin, which is recommended in combination with a boosted protease inhibitor (PI/r) is expensive and not available in Thailand and other developing countries. Ritonavir-boosted indinavir (IDV/r) is potent and the cheapest boosted PI available in Thailand. If IDV/r in combination with rifampin demonstrates suitable pharmacokinetics and is well tolerated, this regimen might prove useful and could be widely implemented. However, high rates of gastrointestinal and renal toxicity have been demonstrated in Thai patients receiving standard doses of IDV/r 800/100 BID. We believe that there is a strong rationale to study if IDV/r 600/100 BID in combination with rifampin is able to produce a satisfactory pharmacokinetic profile, with antiretroviral potency, tolerability and efficacy.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anchalee Avihingsanon, MD | +66 2 2557334-5 ext 107 | anchalee.a@hivnat.org |
Contact: Kiat Ruxrungtham, MD | + 66 2 2557334-5 | rkiat@chula.ac.th |
Thailand | |
HIV-NAT Thai Red Cross AIDS Research Center | Recruiting |
Bangkok, Thailand, 10330 | |
Contact: Anchalee Avihingsanon, MD + 66 2 2557334-5 ext 107 anchalee.a@hivnat.org | |
Contact: Kiat Ruxrungtham, MD +66 2 2557334-5 rkiat@chula.ac.th | |
Principal Investigator: Kiat Ruxrungtham, MD |
Principal Investigator: | Kiat Ruxrungtham, MD | HIV-NAT, Thai Red Cross AIDS Research Center |
Responsible Party: | HIV-NAT ( Kiat Ruxrungtham ) |
Study ID Numbers: | HIV-NAT 044 |
Study First Received: | December 14, 2006 |
Last Updated: | March 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00411996 History of Changes |
Health Authority: | Thailand: Food and Drug Administration |
indinavir/ritonavir HIV/TB rifampicin PK and efficacy of IDV/RTV 600/100 mg BID with rifampicin Treatment Naive |
Bacterial Infections HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Anti-HIV Agents Indinavir Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases Anti-Bacterial Agents |
Rifampin Gram-Positive Bacterial Infections Anti-Retroviral Agents HIV Infections Ritonavir Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Antitubercular Agents Retroviridae Infections |
Bacterial Infections Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Indinavir Infection Rifampin Anti-Bacterial Agents Gram-Positive Bacterial Infections Anti-Retroviral Agents Therapeutic Uses Tuberculosis Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Actinomycetales Infections Pharmacologic Actions Protease Inhibitors Antibiotics, Antitubercular Virus Diseases HIV Infections Ritonavir |