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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00476853
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : June 7, 2010
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Tuberculosis Drug: HAART containing nevirapine Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Study Start Date : October 2005
Primary Completion Date : September 2008
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Safety and tolerability of nevirapine based HAART 400 mg/day versus 600 mg/day [ Time Frame: 48 weeks ]
  2. Nevirapine level at week 2, 4 and 12 and 12 hour PK at week 4 (only 20 patients) [ Time Frame: 48 weeks ]
  3. Immune recovery syndrome, adherence, clinical improvement, incidence of new/recurrent AIDS events (CDC class C) between two group [ Time Frame: 48 weeks ]
  4. 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 ]

Eligibility Criteria

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

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476853

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 GPO
Bamrasnaradura Infectious Diseases Institute
Chiang Rai Hospital
King Chulalongkorn Memorial Hospital
Central General Chest Institute
The Research Institute of Tuberculosis (Japan)
Principal Investigator: Anchalee Avihingsanon, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anchalee Avihingsanon, HIV-NAT
ClinicalTrials.gov Identifier: NCT00476853     History of Changes
Other Study ID Numbers: HIV-NAT 033
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: June 2010

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers