The Pharmacokinetics and Safety of IDV/r With NRTIs in HIV/TB Co-infected Patients Receiving Rifampicin
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- pharmacokinetics of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
- safety of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- efficacy of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- the prevalence of immune recovery syndrome of TB and other HIV-related conditions after ritonavir-boosted indinavir 600/100mg bid [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 20 |
| Study Start Date: | December 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
IDV/r 600/100 mg + rifampicin
|
Drug: indinavir/ritonavir
IDV/r 600/100 mg BID + rifampicin OD for at least 2 weeks
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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%
Contacts and Locations| Thailand | |
| HIV-NAT Thai Red Cross AIDS Research Center | |
| Bangkok, Thailand, 10330 | |
| Principal Investigator: | Kiat Ruxrungtham, MD | HIV-NAT, Thai Red Cross AIDS Research Center |
More Information
Additional Information:
No publications provided by The HIV Netherlands Australia Thailand Research Collaboration
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kiat Ruxrungtham, HIV-NAT |
| ClinicalTrials.gov Identifier: | NCT00411996 History of Changes |
| Other Study ID Numbers: | HIV-NAT 044 |
| Study First Received: | December 14, 2006 |
| Last Updated: | June 4, 2010 |
| Health Authority: | Thailand: Food and Drug Administration |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
indinavir/ritonavir HIV/TB rifampicin PK and efficacy of IDV/RTV 600/100 mg BID with rifampicin Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Rifampin Indinavir Ritonavir Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antitubercular Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013