Trial record 5 of 6 for:    " December 04, 2006":" December 14, 2006"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

The Pharmacokinetics and Safety of IDV/r With NRTIs in HIV/TB Co-infected Patients Receiving Rifampicin

This study has been completed.
Sponsor:
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00411996
First received: December 14, 2006
Last updated: June 4, 2010
Last verified: June 2010
  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

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411996

Locations
Thailand
HIV-NAT Thai Red Cross AIDS Research Center
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Investigators
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 August 01, 2014