Clinical Trials

MainTitle

Efficacy Safety Study Comparing 2 Doses of NVP After Initiating Rifampin-containing TB Therapy

This study has been completed
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration

Collaborator
other sponsors:Japanese MOPH
Labor and Welfare
Thai MOPH
Thai GPO
Bamrasnaradura Infectious Diseases Institute
Chiang Rai Hospital
King Chulalongkorn Memorial Hospital
Central General Chest Institute
The Research Institute of Tuberculosis (Japan)

Information provided by (Responsible Party)
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier
NCT00476853

First received: May 20, 2007
Last updated: June 4, 2010
Last Verified: June 2010
History of Changes
Purpose

Purpose

A 48 week, randomized, open-label, two arm study to compare the efficacy, safety and tolerability of HAART containing nevirapine 400 mg/day versus nevirapine 600 mg/day in HIV-1 infected patients started at 2-6 weeks after initiating rifampicin containing antituberculosis therapy.

Condition Intervention Phase
HIV Infections
Tuberculosis

Drug : HAART containing nevirapine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 48 Week, Randomized, Open-label, 2 Arm Study to Compare the Efficacy, Safety and Tolerability of HAART Containing Nevirapine 400mg/Day Versus Nevirapine 600 mg/Day in HIV-1 Infected Patients Started at 2-6 Weeks After Initiating Rifampin Containing Antituberculous Therapy

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

Primary Outcome Measures

  • Efficacy of nevirapine based HAART 400 mg/day versus 600 mg/day on HIV-1 load as measured by HIV-1 RNA quantification in plasma [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
  • Safety and tolerability of nevirapine based HAART 400 mg/day versus 600 mg/day [ Time Frame: 48 weeks ]
  • Nevirapine level at week 2, 4 and 12 and 12 hour PK at week 4 (only 20 patients) [ Time Frame: 48 weeks ]
  • Immune recovery syndrome, adherence, clinical improvement, incidence of new/recurrent AIDS events (CDC class C) between two group [ Time Frame: 48 weeks ]
  • Time to mortality or new/recurrent AIDS events (CDC class C), 1 year mortality rate of TB/HIV patients, emerging of ARV resistant especially nevirapine, emerging of anti-TB resistance [ Time Frame: 48 weeks ]

Enrollment: 42
Study Start Date: October 2005
Study Completion Date: December 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: 1
NVP 400 mg
Drug: HAART containing nevirapine

Initially NVP 200 mg BID (400 mg per day) was compared to 400 mg BID and 200 mg OD NVP (600 mg per day). 400 mg/day versus 600 mg/day.

Active Comparator: 2
NVP 600 mg
Drug: HAART containing nevirapine

Initially NVP 200 mg BID (400 mg per day) was compared to 400 mg BID and 200 mg OD NVP (600 mg per day). 400 mg/day versus 600 mg/day.

Detailed Description:

Preliminary data from the HIVNAT PK laboratory indicate that out of 5/60 patients treated with nevirapine (200 mg bid) and rifampicin had sub-therapeutic nevirapine levels (<3.0 mg mg/L). In a control group of 38 patients using nevirapine without rifampicin there were no sub-therapeutic levels. A dose increase of nevirapine while patients who are receiving that rifampicin may be required. Both nevirapine and rifampicin are tepatotoxic agents as are other agents used in treatment of HIV or tuberculosis. Using a higher nevirapine may prevent the occurrence of sub-therapeutic nevirapine levels, but may also induce more liver toxicity. To address these issues, we designed a randomized prospective study to evaluate the safety, efficacy and pharmacokinetics of nevirapine 400 mg/day versus 600 mg/day with a two weeks lead-in 200 mg/day and 400 mg/day respectively, in TB-HIV co-infected patients who taking rifampicin and short-term efficacy and toxicity.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 60 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. Confirmed HIV positive after voluntary counseling and testing
    2. Aged 18-60 years of age
    3. Antiretroviral treatment naïve.
    4. CD4+ cell count of < 200 cells/mm3 at the time of diagnosed TB
    5. TB is diagnosed and using treatment with rifampin base therapy for at least 2 weeks but no longer than 4 weeks duration. The requirement for study entry is at least one acid-fast bacillus (AFB) positive smear with a typical syndrome and/or CXR findings consistent with pulmonary TB. Pulmonary TB and / or extra pulmonary TB will be included if AFB or culture for TB is positive.
    6. No other active OI (CDC class C event)
    7. Negative pregnancy test in females, and willing to use reliable contraception
    8. Able to provide written informed consent.


Exclusion Criteria:
    1. The following laboratory variables, i. absolute neutrophil count (ANC) < 1000 cells/uL ii. hemoglobin < 6.5 g/dL iii. platelet count < 50,000 cells/uL iv. serum AST, ALT > 5 x ULN vi. serum bilirubin > 2 x ULN vii. serum creatinine > 2 x ULN viii. Pregnant or nursing mothers.
    2. Current use of steroid and other immunosuppressive agents.
    3. Current use of any prohibited medications related to compliance and drug pharmacokinetics (see appendix )
    4. Acute therapy for serious infection or other serious medical illness (in the judgment of the site Principal Investigator) requiring systemic treatment and/or hospitalization.
    5. 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.
    6. The persons who had been received a mono-therapy of nevirapine
    7. Unlikely to be able to remain in follow-up for the protocol defined period.
    8. Patients with chronic active liver disease.
    9. Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST < 5 x ULN.
    10. Karnofsky performance score <30%

contacts and locations

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: NCT00476853

Locations

Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Thailand, 10330
Chiangrai Hospital
Chiang Rai, Thailand, 57000
Mae Chan Hospital
Chiang Rai, Thailand, 57000
Phan Hospital
Chiang Rai, Thailand, 57000
Bamrasnaradura Institute
Nonthaburi, Thailand, 11000
Central Chest Hospital
Nonthaburi, Thailand, 11000

Sponsors and Collaborators

The HIV Netherlands Australia Thailand Research Collaboration
other sponsors:Japanese MOPH
Labor and Welfare
Thai MOPH
Thai GPO
Bamrasnaradura Infectious Diseases Institute
Chiang Rai Hospital
King Chulalongkorn Memorial Hospital
Central General Chest Institute
The Research Institute of Tuberculosis (Japan)

Investigators

Principal Investigator: Anchalee Avihingsanon, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
More Information

More Information

Additional Information:

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Responsible Party: Anchalee Avihingsanon, HIV-NAT  
ClinicalTrials.gov Identifier: NCT00476853   History of Changes  
Other Study ID Numbers: HIV-NAT 033  
Study First Received: May 20, 2007  
Last Updated: June 4, 2010  

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

HIV-TB
nevirapine based HAART with rifampin treated TB
Compare PK profile, efficacy, safety and tolerability of HAART containing nevirapine 400mg/day versus 600 mg/day in HIV/TB co-infected patients
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Tuberculosis
Rifampin
Nevirapine

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.