HIV InfectionsNCT00102986
Differences in Blood Levels of Lopinavir/Ritonavir in HIV Infected Men and Women
A study testing Lopinavir/ritonavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 29 sites in 2 countries.
Trial summary
Men's and women's bodies may process anti-HIV drugs differently. The purpose of this study is to determine the differences in blood levels of soft gel capsules and tablets of lopinavir/ritonavir (LPV/r) in HIV infected men and women. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lopinavir/ritonavir
- How many people
- 116 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Oct 2005to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV infected
- Have taken twice-daily LPV/r (soft gel formulation for Step 1 participants and tablet formulation for Step 2 participants) for at least 14 days immediately prior to step screening and are willing to continue taking LPV/r until the PK visit of that step
- Have taken LPV/r in combination with at least one of the following for at least 14 days immediately prior to study step screening: zidovudine, lamivudine, emtricitabine, stavudine, abacavir sulfate, didanosine, zalcitabine, tenofovir disoproxil fumarate, enfuvirtide, AND are willing to continue taking them until the PK visit of that step
- Body weight of more than 50 kg (110 lbs) for Step 1 participants only
Who cannot join
- Non-nucleoside reverse transcriptase inhibitor or dual protease inhibitor regimen within 30 days prior to study entry
- Require certain medications
- Current drug or alcohol abuse that, in the investigator's opinion, may interfere with the study
- Serious illness requiring systemic treatment or hospitalization within 30 days of study screening
- Acute AIDS-related opportunistic infection within 90 days of study entry
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States28 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80045
Johns Hopkins University CRS
Baltimore, Maryland, 21205
Bmc Actg Crs
Boston, Massachusetts, 02118
Chapel Hill CRS
Chapel Hill, North Carolina, 27599
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612
Rush University CRS
Chicago, Illinois, 60612
Cincinnati CRS
Cincinnati, Ohio, 45219
MetroHealth CRS
Cleveland, Ohio, 44109
Ohio State University CRS
Columbus, Ohio, 43210
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 77555-0435
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202-5250
University of Southern California CRS
Los Angeles, California, 90033-1079
UCLA CARE Center CRS
Los Angeles, California, 90035
The University of Miami AIDS Clinical Research Unit (ACRU) CRS
Miami, Florida, 33136
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, 37204
Beth Israel Med. Ctr., ACTU
New York, New York, 10003
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Columbia P&S CRS
New York, New York, 10032-3732
Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, 94304-5350
Penn Therapeutics, CRS
Philadelphia, Pennsylvania, 19104
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
UCSD Antiviral Research Center CRS
San Diego, California, 92103
University of Washington AIDS CRS
Seattle, Washington, 98104-9929
Washington University Therapeutics (WT) CRS
St Louis, Missouri, 63110-1010
Harbor-UCLA CRS
Torrance, California, 90502
Georgetown University CRS (GU CRS)
Washington D.C., District of Columbia, 20007
Puerto Rico1 site
Puerto Rico AIDS Clinical Trials Unit CRS
San Juan, 00935
About this study
Official title: Sex Differences in Lopinavir/Ritonavir Pharmacokinetics Among HIV-1-Infected Men and Women
Men's and women's bodies may process anti-HIV drugs differently. The purpose of this study is to determine the differences in blood levels of soft gel capsules and tablets of lopinavir/ritonavir (LPV/r) in HIV infected men and women.
Read the detailed description
It is estimated that 50% of people living with HIV/AIDS worldwide are women. HIV infected women face different psychosocial issues than men, and their bodies may react differently to HIV treatment. However, most of the data on the safety and efficacy of antiretrovirals (ARVs) used in the treatment of HIV infection are from studies conducted primarily in men. LPV/r in tablet form was approved by the FDA in October 2005. This study will determine the differences in pharmacokinetics (PK) in men and women taking a soft gel capsule and a tablet formulation of LPV/r.
No ARVs will be provided by this study. In Step 1, participants will receive soft gel capsules of LPV/r. All Step 1 participants will be asked to join Step 2 of the study upon completion of Step 1. In Step 2, participants will receive tablets of LPV/r. During the study, participants in both Step 1 and 2 will take a treatment regimen of LPV/r twice daily and one or more of the following: a nucleoside reverse transcriptase inhibitor (NRTI), tenofovir disoproxil fumarate, or enfuvirtide. Medical and medication history, blood collection, and clinical assessments will occur at study screening for both Steps 1 and 2. Participants in both steps will be asked to complete a medication diary from study entry to the day of the PK visit. The PK visit will occur within 30 days of study screening; blood collection for PK analysis will also occur at this visit.
- Conditions
- HIV Infections
- Being tested
- Lopinavir/ritonavir
- Keywords
- Kaletra, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/ritonavirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours
Secondary outcomes (7)
LPV maximum concentration (Cmax), concentration at 12 hours (C12h), and apparent oral clearance (CL/F)
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and participant's race and ethnicity
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, participant's age, weight, and body mass index (BMI), and coadministration of TDF
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and graded signs and symptoms
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and graded gastrointestinal signs and symptoms (defined as nausea, vomiting, diarrhea, abdominal pain, and bloating)
ritonavir (RTV) AUC for 0 to 12 hours, Cmax, C12h, and CL/F
LPV/r AUC for 0 to 12 hours, Cmax, C12h, CL/F for both the soft gel capsule and tablet formulations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2005 (estimated)
- Study startOct 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 116 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Responsible party
- Sponsor
- Investigators
- Judith S. Currier, MD, MSc, Study chair, Center for AIDS Research and Education, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102986
- Sponsor's protocol ID
- A5223
- Other IDs
- ACTG A5223, 10026
- Status last verified
- Dec 2015
- First submitted
- 4 Feb 2005
- Last updated
- 3 Dec 2015
- Results posted
- No
Publications
Umeh OC, Currier JS. Sex Differences in HIV: Natural History, Pharmacokinetics, and Drug Toxicity. Curr Infect Dis Rep. 2005 Jan;7(1):73-78. doi: 10.1007/s11908-005-0026-9.
PubMed 15610674
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Lopinavir/Ritonavir Pharmacokinetics Among HIV-1-Infected Men and Women
- ClinicalTrials.gov ID
- NCT00102986
- Acronym / sponsor ID
- A5223
- Conditions
- HIV Infections
- Keywords
- Kaletra, Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Study start
- Oct 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 7 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Men's and women's bodies may process anti-HIV drugs differently. The purpose of this study is to determine the differences in blood levels of soft gel capsules and tablets of lopinavir/ritonavir (LPV/r) in HIV infected men and women.
Detailed description
It is estimated that 50% of people living with HIV/AIDS worldwide are women. HIV infected women face different psychosocial issues than men, and their bodies may react differently to HIV treatment. However, most of the data on the safety and efficacy of antiretrovirals (ARVs) used in the treatment of HIV infection are from studies conducted primarily in men. LPV/r in tablet form was approved by the FDA in October 2005. This study will determine the differences in pharmacokinetics (PK) in men and women taking a soft gel capsule and a tablet formulation of LPV/r.
No ARVs will be provided by this study. In Step 1, participants will receive soft gel capsules of LPV/r. All Step 1 participants will be asked to join Step 2 of the study upon completion of Step 1. In Step 2, participants will receive tablets of LPV/r. During the study, participants in both Step 1 and 2 will take a treatment regimen of LPV/r twice daily and one or more of the following: a nucleoside reverse transcriptase inhibitor (NRTI), tenofovir disoproxil fumarate, or enfuvirtide. Medical and medication history, blood collection, and clinical assessments will occur at study screening for both Steps 1 and 2. Participants in both steps will be asked to complete a medication diary from study entry to the day of the PK visit. The PK visit will occur within 30 days of study screening; blood collection for PK analysis will also occur at this visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infected
- Have taken twice-daily LPV/r (soft gel formulation for Step 1 participants and tablet formulation for Step 2 participants) for at least 14 days immediately prior to step screening and are willing to continue taking LPV/r until the PK visit of that step
- Have taken LPV/r in combination with at least one of the following for at least 14 days immediately prior to study step screening: zidovudine, lamivudine, emtricitabine, stavudine, abacavir sulfate, didanosine, zalcitabine, tenofovir disoproxil fumarate, enfuvirtide, AND are willing to continue taking them until the PK visit of that step
- Body weight of more than 50 kg (110 lbs) for Step 1 participants only
Key exclusion criteria (5 listed)
- Non-nucleoside reverse transcriptase inhibitor or dual protease inhibitor regimen within 30 days prior to study entry
- Require certain medications
- Current drug or alcohol abuse that, in the investigator's opinion, may interfere with the study
- Serious illness requiring systemic treatment or hospitalization within 30 days of study screening
- Acute AIDS-related opportunistic infection within 90 days of study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lopinavir/ritonavir | Drug | – |
Primary outcome
Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours
7 secondary outcomes
LPV maximum concentration (Cmax), concentration at 12 hours (C12h), and apparent oral clearance (CL/F)
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and participant's race and ethnicity
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, participant's age, weight, and body mass index (BMI), and coadministration of TDF
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and graded signs and symptoms
LPV AUC for 0 to 12 hours, Cmax, C12h, CL/F, and graded gastrointestinal signs and symptoms (defined as nausea, vomiting, diarrhea, abdominal pain, and bloating)
ritonavir (RTV) AUC for 0 to 12 hours, Cmax, C12h, and CL/F
LPV/r AUC for 0 to 12 hours, Cmax, C12h, CL/F for both the soft gel capsule and tablet formulations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Background: PubMed 15610674Umeh OC, Currier JS. Sex Differences in HIV: Natural History, Pharmacokinetics, and Drug Toxicity. Curr Infect Dis Rep. 2005 Jan;7(1):73-78. doi: 10.1007/s11908-005-0026-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith S. Currier, MD, MSc study chair
Center for AIDS Research and Education, University of California, Los Angeles
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lopinavir/ritonavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 29 sites in 2 countries.
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 4 inclusion and 5 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Puerto Rico. 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?
Lopinavir (LPV) area under the concentration-time curve (AUC) for 0 to 12 hours. 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 NCT00102986, which also lists 1 linked publication.
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 3 Dec 2015.