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HIV InfectionsPhase 2NCT00000913

A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children

A Phase 2 study testing Ritonavir, Nelfinavir mesylate and Saquinavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 36 sites in 2 countries.

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

The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs. Read more about this study

Who is it for?
Ages 3 to 16 years
Conditions the study is for
HIV Infections
What is being tested?
Ritonavir, Nelfinavir mesylate and Saquinavir
How many people
50 participants
Where
36 sitesin 2 countries
Study dates
Start not givento Apr 2001
Phase
Phase 2
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 3 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Your child may be eligible for this study if he or she:
  • Is HIV-positive.
  • Is 3 to 16 years of age (consent of parent or guardian is required).
  • Has an HIV level greater than 10,000 copies/ml.
  • Has never taken at least one of the following anti-HIV drugs: lamivudine, zidovudine, stavudine, or didanosine.
  • Is able to swallow capsules and tablets.

Who cannot join

  • Your child will not be eligible if he or she:
  • Has cancer requiring chemotherapy.
  • Has an acute opportunistic (AIDS-related) infection requiring therapy.
  • Has had two or more episodes of moderate or severe diarrhea or vomiting in the 3 months prior to study entry.
  • Has ever taken SQV or NFV.
  • Is pregnant or breast-feeding.
  • Is taking certain medications, including those that would interfere with the study drugs.

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States33 sites

  • Children's Hosp at Albany Med Ctr

    Albany, New York, 12208

  • Emory Univ Hosp / Pediatrics

    Atlanta, Georgia, 30306

  • Univ of Maryland at Baltimore / Univ Med Ctr

    Baltimore, Maryland, 21201

  • Univ of Alabama at Birmingham / Childrens Hosp of AL

    Birmingham, Alabama, 352330011

  • Univ of Alabama at Birmingham - Pediatric

    Birmingham, Alabama, 35233

  • Children's Hosp of Boston

    Boston, Massachusetts, 021155724

  • Med Univ of South Carolina

    Charleston, South Carolina, 294253312

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Univ of Illinois College of Medicine / Pediatrics

    Chicago, Illinois, 60612

  • Chicago Children's Memorial Hosp

    Chicago, Illinois, 606143394

  • North Shore Univ Hosp

    Great Neck, New York, 11021

  • Univ of Mississippi Med Ctr

    Jackson, Mississippi, 39213

  • Long Beach Memorial (Pediatric)

    Long Beach, California, 90801

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • Univ of Miami (Pediatric)

    Miami, Florida, 33161

  • Yale Univ Med School

    New Haven, Connecticut, 06504

  • Tulane Univ / Charity Hosp of New Orleans

    New Orleans, Louisiana, 701122699

  • Cornell Univ Med College

    New York, New York, 10021

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Harlem Hosp Ctr

    New York, New York, 10037

  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp

    Newark, New Jersey, 071032714

  • Children's Hosp of Oakland

    Oakland, California, 946091809

  • Saint Christopher's Hosp for Children

    Philadelphia, Pennsylvania, 191341095

  • Med College of Virginia

    Richmond, Virginia, 23219

  • Palm Beach County Health Dept

    Riviera Beach, Florida, 33404

  • UCSF / Moffitt Hosp - Pediatric

    San Francisco, California, 941430105

  • Children's Hospital & Medical Center / Seattle ACTU

    Seattle, Washington, 981050371

  • Baystate Med Ctr of Springfield

    Springfield, Massachusetts, 01199

  • State Univ of New York at Stony Brook

    Stony Brook, New York, 117948111

  • Bronx Lebanon Hosp Ctr

    The Bronx, New York, 10457

  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr

    The Bronx, New York, 10461

  • Howard Univ Hosp

    Washington D.C., District of Columbia, 20060

Other trials in United States

Puerto Rico3 sites

  • Ramon Ruiz Arnau Univ Hosp / Pediatrics

    Bayamón, 00956

  • Univ of Puerto Rico / Univ Children's Hosp AIDS

    San Juan, 009365067

  • San Juan City Hosp

    San Juan, 009367344

Other trials in Puerto Rico

About this study

Official title: A Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children With HIV Infection

The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs.

SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors.

Read the detailed description

Clinical trials in adults and children suggest that SQV-SGC has advantages over other protease inhibitors in terms of tolerability, safety, and effectiveness in patients who have failed therapy with other protease inhibitors. [AS PER AMENDMENT 11/24/99: Pharmacokinetic data from this study demonstrate lower than expected plasma SQV exposures, particularly in Arm 1. Based on these data, patients in the study will be offered the opportunity to adjust their doses. Ritonavir added to the Arm 1 regimen is expected to significantly increase SQV-SGC plasma levels and allow twice-daily dosing for SQV-SGC.]

Patients are randomized to one of two study arms. Patients in Arm 1 receive SQV-SGC plus two [AS PER AMENDMENT 11/24/99: one or two] NRTIs of choice. Patients in Arm 2 receive SQV-SGC plus NFV plus one or two NRTIs of choice. All participants are evaluated by physical examinations and laboratory tests during the study and are followed for incidence of death, cancer, or fetal abnormality. NRTIs are not provided as part of this study. [AS PER AMENDMENT 11/24/99: This study is closed to accrual. All subjects on follow-up (Cohort 1) are given the option of either discontinuing participation in ACTG 397 or participating in the next phase of the study (version 2.0). Those electing to continue participation constitute Cohort 1A. The adjusted Arm 1 regimen consists of SQV-SGC plus ritonavir plus one or two NRTIs. Ritonavir is not provided as part of this study. The Arm 2 regimen study drugs have not changed but the maximum allowable dose of SQV-SGC has increased from 1,200 mg twice-daily to 1,600 mg twice-daily. Participants continue to be followed with physical examinations and laboratory evaluations that include an intensive pharmacokinetics study on Day 14 of the new regimen.]

Conditions
HIV Infections
Being tested
Ritonavir, Nelfinavir mesylate, Saquinavir
Keywords
Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
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.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionApr 2001

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 2
Primary purpose
Treatment
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000913
Sponsor's protocol ID
ACTG 397
Other IDs
11353
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
29 Oct 2021
Results posted
No

Publications

  • Brundage RC, Kline MW, Lindsey J, Fenton T, Fletcher CV. Pharmacokinetics of saquinavir (SQV) with nelfinavir (NFV) or ritonavir (RTV) in HIV-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 728)

  • Kline MW, Fletcher CV, Lindsey JC, Fenton T. A randomized trial of two saquinavir (SQV-SGC)-containing combination treatment regimens in HIV-infected children. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 694]

  • Kline MW, Fletcher CV, Lindsey JC, Fenton T. A randomized trial of combination therapy with saquinavir soft gelatin capsules (SQV) in HIV-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 683)

  • Brundage RC, Kline MW, Lindsey JC, Fenton T, Fletcher CV. Pharmacokinetics (PK) of saquinavir (SQV) and nelfinavir (NFV) in a twice-daily (BID) regimen in HIV-infected children. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 718]

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ritonavir, Nelfinavir mesylate and Saquinavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 36 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 6 inclusion and 7 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 36 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 NCT00000913, which also lists 4 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 29 Oct 2021.

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