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HIV InfectionsNCT00096850

Safety, Tolerability, and Blood Levels of Ritonavir-Boosted Atazanavir and Rifampin When Taken Together in HIV Uninfected Adults

A study testing Atazanavir, Rifampin and Ritonavir in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Rifampin (RIF) is used for the treatment of tuberculosis (TB), an infectious disease that affects many people with HIV. RIF was shown to lower concentrations and decrease the effectiveness of some anti-HIV drugs, including the HIV protease inhibitor (PI) atazanavir (ATV) boosted with ritonavir (RTV). Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections, Tuberculosis
What is being tested?
Atazanavir, Rifampin and Ritonavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
3 sitesUnited States
Study dates
Start not givento Dec 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • HIV uninfected
  • Normal creatinine clearance
  • Willing to use acceptable means of contraception during the study and for at least 6 weeks after stopping study medications

Who cannot join

  • Using or anticipating use of certain medications, including any medication metabolized by CYP3A
  • Active drug use or dependence that, in the opinion of the investigator, may interfere with the study
  • Cannot stop consuming alcoholic beverages, grapefruit, or grapefruit juice for the duration of the study
  • Cannot stop consuming coffee or caffeine-containing products for 12 hours prior to Day 8, 19, and 27 PK studies
  • Serious illness that, in the opinion of the investigator, may interfere with the study
  • Hospitalization for any reason within 14 days prior to study entry
Show all 11Show fewer
  • History of hypersensitivity to study drugs or their formulations
  • Active or previous history of cardiovascular, kidney, liver, blood, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease. Patients with chronic illnesses such as hypertension, coronary heart disease, arthritis, diabetes, or chronic gastrointestinal conditions that may affect drug absorption are also excluded.
  • ECG showing first-degree or greater heart block or a QT interval greater than 440 msec within 30 days of study entry
  • Previous participation in this study
  • Pregnancy or breastfeeding

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The Ohio State Univ. AIDS CRS

    Columbus, Ohio, 43210

  • Vanderbilt Therapeutics CRS

    Nashville, Tennessee, 37203

  • Stanford CRS

    Palo Alto, California, 94305-5107

Other trials in United States

About this study

Official title: Safety, Tolerability, and Pharmacokinetic Interactions of Atazanavir and Rifampin in Healthy Volunteers

Rifampin (RIF) is used for the treatment of tuberculosis (TB), an infectious disease that affects many people with HIV. RIF was shown to lower concentrations and decrease the effectiveness of some anti-HIV drugs, including the HIV protease inhibitor (PI) atazanavir (ATV) boosted with ritonavir (RTV). The purpose of this study is to determine the interactions between RTV-boosted ATV and evaluate the safety and tolerability of giving these drugs together in HIV uninfected adults.

Read the detailed description

TB is common in resource-limited countries, and people infected with HIV are especially at risk for TB infection. The antituberculous drug RIF lowers plasma concentrations of PIs by increasing the activity of enzymes responsible for PI breakdown. RIF has been shown to reduce PI effectiveness, a particular concern for HIV infected patients who are also being treated for TB. RTV has been shown to delay the plasma clearance of ATV and increase the plasma half-life of ATV. This study will evaluate the safety, tolerability, and pharmacokinetic (PK) interactions of RTV-boosted ATV, taken concurrently with RIF in HIV uninfected people.

Medical and medication history, a complete physical exam, blood collection, and an electrocardiogram (ECG) will occur at screening. Participants will be enrolled in this study for 41 to 58 days; there will be 3 dosing periods. From Days 1 to 8, participants will receive 600 mg RIF every 24 hours. From Days 9 to 19, participants will receive 300 mg ATV and 100 mg RTV every 12 hours and 600 mg RIF every 24 hours. From Days 20 to 27, participants will receive 400 mg ATV and 100 mg RTV every 12 hours and 600 mg RIF every 24 hours. Study visits will occur at entry; at Days 5, 8, 11, 14, 19, 23, and 27; and at an additional visit between Days 41 and 48. Blood and urine collection will occur at all visits. A targeted physical exam, an ECG, and blood collection for PK analysis will occur at Days 8, 19, and 27.

Being tested
Atazanavir, Rifampin, Ritonavir
Keywords
HIV Seronegativity, Antitubercular agents
Medical subject headings
HIV Infections, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtazanavirDrug

    Also called ATV

    From Days 9 to 19, participants will receive a 300 mg tablet orally daily. From Days 20 to 27, participants will receive a 400 mg tablet orally daily.

  • RifampinDrug

    Also called RIF

    From Days 1 to 27, participants will receive a 600 mg tablet orally daily.

  • RitonavirDrug

    Also called RTV

    From Days 9 to 19, participants will receive a 100 mg tablet orally daily. From Days 20 to 27, participants will receive a 100 mg tablet orally twice daily.

Study groups in NCT00096850
Study groupRoleWhat they receive
1ExperimentalFrom Days 1 to 8, participants will receive 600 mg RIF every 24 hours. From Days 9 to 19, participants will receive 300 mg ATV and 100 mg RTV every 12 hours and 600 mg RIF every 24 hours. From Days 20 to 27, participants will receive 400 mg ATV and 100 mg RTV every 12 hours and 600 mg RIF every 24 hours.
Receives: Drug: Atazanavir; Drug: Rifampin; Drug: Ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic parameters of ritonavir (RTV)-boosted ATV when administered concurrently with RIF

    Measured: Throughout study

  2. Safety and tolerability of RTV-boosted ATV when coadministered with RIF

    Measured: Throughout study

Secondary outcomes (5)

  1. Pharmacokinetics of RIF

    Measured: Throughout study

  2. Copy number of cellular drug transporter RNA in peripheral blood mononuclear cells (PBMCs)

    Measured: Throughout study

  3. UDP-glucuronosyltransferase (UGT)-1A1 genotype

    Measured: At study entry

  4. Serum bilirubin concentration

    Measured: Throughout study

  5. urine thromboxane and prostacyclin concentrations

    Measured: At study entry and first PK visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2004 (estimated)
  2. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096850
Sponsor's protocol ID
A5213
Other IDs
10021, ACTG A5213
Status last verified
Oct 2021
First submitted
16 Nov 2004
Last updated
1 Nov 2021
Results posted
No

Publications

  • Finch CK, Chrisman CR, Baciewicz AM, Self TH. Rifampin and rifabutin drug interactions: an update. Arch Intern Med. 2002 May 13;162(9):985-92. doi: 10.1001/archinte.162.9.985.

    PubMed 11996607

  • Fujiwara PI, Clevenbergh P, Dlodlo RA. Management of adults living with HIV/AIDS in low-income, high-burden settings, with special reference to persons with tuberculosis. Int J Tuberc Lung Dis. 2005 Sep;9(9):946-58.

    PubMed 16158886

  • Kashuba AD. Drug-drug interactions and the pharmacotherapy of HIV infection. Top HIV Med. 2005 Jun-Jul;13(2):64-9.

    PubMed 16082056

  • Musial BL, Chojnacki JK, Coleman CI. Atazanavir: a new protease inhibitor to treat HIV infection. Am J Health Syst Pharm. 2004 Jul 1;61(13):1365-74. doi: 10.1093/ajhp/61.13.1365.

    PubMed 15287232

  • Orrick JJ, Steinhart CR. Atazanavir. Ann Pharmacother. 2004 Oct;38(10):1664-74. doi: 10.1345/aph.1D394. Epub 2004 Sep 7.

    PubMed 15353575

  • Acosta EP, Kendall MA, Gerber JG, Alston-Smith B, Koletar SL, Zolopa AR, Agarwala S, Child M, Bertz R, Hosey L, Haas DW. Effect of concomitantly administered rifampin on the pharmacokinetics and safety of atazanavir administered twice daily. Antimicrob Agents Chemother. 2007 Sep;51(9):3104-10. doi: 10.1128/AAC.00341-07. Epub 2007 Jun 18.

    PubMed 17576825

Questions about this trial

What is this clinical trial studying?

A study testing Atazanavir, Rifampin and Ritonavir in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic parameters of ritonavir (RTV)-boosted ATV when administered concurrently with RIF (time frame: Throughout study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00096850, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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