HIV InfectionsNCT00000898
The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir
A study testing Ritonavir, Nelfinavir mesylate and Saquinavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and saquinavir has any effect on the interactions between these drugs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ritonavir, Nelfinavir mesylate and Saquinavir
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- Start not givento May 2000
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must have:
- Absence of HIV-1 infection as documented by any licensed ELISA test kit within 14 days prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Any medical condition that, in the opinion of the investigator, would interfere with the patient's ability to participate in this protocol.
- Patients with the following prior conditions and symptoms are excluded:
- History of chronic illness such as hypertension, coronary artery disease, arthritis, diabetes, or any chronic gastrointestinal conditions that might interfere with drug absorption.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
San Francisco Gen Hosp
San Francisco, California, 941102859
Univ of California/ San Francisco / Dept of Medicine
San Francisco, California, 94110
Stanford Univ Med Ctr
Stanford, California, 943055107
About this study
Official title: A Prototype Study to Test the Effect of Staggered Dosing on the Pharmacokinetic Interactions Between Paired Combinations of Nelfinavir (NFV), Ritonavir (RTV), and Soft Gelatin Capsule of Saquinavir (SQVsgc)
The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and saquinavir has any effect on the interactions between these drugs.
- Conditions
- HIV Infections
- Being tested
- Ritonavir, Nelfinavir mesylate, Saquinavir
- Keywords
- Drug Interactions, Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Ritonavir, Nelfinavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitonavirDrug
Nelfinavir mesylateDrug
SaquinavirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionMay 2000
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
- Enrolment
- 18 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Blaschke T, Study chairFlexner C, Study chairSheiner L, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000898
- Sponsor's protocol ID
- ACTG 378
- Other IDs
- 11339
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Publications
Washington CB, Flexner C, Sheiner LB, Rosenkranz SL, Segal Y, Aberg JA, Blaschke TF; AIDS Clinical Trials Group Protocol (ACTG 378) Study Team. Effect of simultaneous versus staggered dosing on pharmacokinetic interactions of protease inhibitors. Clin Pharmacol Ther. 2003 May;73(5):406-16. doi: 10.1016/s0009-9236(03)00006-7.
PubMed 12732841
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prototype Study to Test the Effect of Staggered Dosing on the Pharmacokinetic Interactions Between Paired Combinations of Nelfinavir (NFV), Ritonavir (RTV), and Soft Gelatin Capsule of Saquinavir (SQVsgc)
- ClinicalTrials.gov ID
- NCT00000898
- Acronym / sponsor ID
- ACTG 378
- Conditions
- HIV Infections
- Keywords
- Drug Interactions, Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Ritonavir, Nelfinavir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 2000 (actual)
- First posted
- 31 Aug 2001 (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.
The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and saquinavir has any effect on the interactions between these drugs.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Absence of HIV-1 infection as documented by any licensed ELISA test kit within 14 days prior to study entry.
Key exclusion criteria (5 listed)
- Any medical condition that, in the opinion of the investigator, would interfere with the patient's ability to participate in this protocol.
- History of chronic illness such as hypertension, coronary artery disease, arthritis, diabetes, or any chronic gastrointestinal conditions that might interfere with drug absorption.
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 |
|---|---|---|
| Ritonavir | Drug | – |
| Nelfinavir mesylate | Drug | – |
| Saquinavir | Drug | – |
Primary outcome
Not reported in the source record.
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 29 Oct 2021.
- Background: PubMed 12732841Washington CB, Flexner C, Sheiner LB, Rosenkranz SL, Segal Y, Aberg JA, Blaschke TF; AIDS Clinical Trials Group Protocol (ACTG 378) Study Team. Effect of simultaneous versus staggered dosing on pharmacokinetic interactions of protease inhibitors. Clin Pharmacol Ther. 2003 May;73(5):406-16. doi: 10.1016/s0009-9236(03)00006-7.
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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.
Blaschke T study chair
Flexner C study chair
Sheiner L study chair
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ritonavir, Nelfinavir mesylate and Saquinavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 2 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000898, 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 29 Oct 2021.