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AzTrials

HIV InfectionsPhase 2NCT00000848

The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year

A Phase 2 study testing Indinavir sulfate and Saquinavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 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

To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA. 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?
Indinavir sulfate and Saquinavir
How many people
144 participants
Where
16 sitesUnited States
Study dates
Start not givento Oct 1998
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Required:
  • PCP prophylaxis if CD4 count <= 200 cells/mm3.
  • Allowed:
  • Intralesional therapy for KS.
  • Vitamins.
Show all 18Show fewer
  • Nucleoside RT inhibitors, provided regimen remains stable for first 8 weeks of study.
  • Concurrent Treatment:
  • Allowed:
  • Acupuncture.
  • Visualization techniques.
  • Patients must have:
  • HIV infection.
  • Prior hard capsule saquinavir at 1800 mg/day for more than 1 year.
  • Prior Medication:
  • Allowed:
  • Prior saquinavir.
  • Prior antiretrovirals, excluding protease inhibitors other than saquinavir.

Who cannot join

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Psychological condition or medical instability that would interfere with study evaluation or procedures.
  • AS PER AMENDMENT 5/7/97:
  • Active tuberculosis.
  • Concurrent Medication:
Show all 52Show fewer
  • Excluded:
  • Protease inhibitors other than study drugs.
  • Non-nucleoside RT inhibitors.
  • Interferon.
  • Interleukins.
  • GM-CSF.
  • HIV vaccines.
  • Systemic cytotoxic chemotherapy.
  • Investigational drugs other than study medications.
  • Rifabutin.
  • Rifampin.
  • Midazolam.
  • Triazolam.
  • Ketoconazole.
  • Delavirdine.
  • Cisapride.
  • Terfenadine.
  • Astemizole.
  • AS PER AMENDMENT 5/7/97:
  • Nevirapine.
  • Patients with the following prior conditions are excluded:
  • Unexplained fever > 38.5 C for any 7 days within 30 days prior to study entry.
  • Diarrhea persisting for 15 days within 30 days prior to study entry.
  • Prior Medication:
  • Excluded:
  • Any prior protease inhibitor other than saquinavir.
  • Excluded within the past 2 months.
  • Change in antiretroviral regimen.
  • Systemic chemotherapy for KS.
  • Excluded within the past month:
  • Non-nucleoside RT inhibitors.
  • Interferons.
  • Interleukins.
  • HIV vaccines.
  • Experimental therapies.
  • Excluded within the past 2 weeks:
  • Rifabutin.
  • Cisapride.
  • Terfenadine.
  • Astemizole.
  • Midazolam.
  • Triazolam.
  • Oral ketoconazole.
  • Delavirdine.
  • Acute therapy for infection or other medical illness.
  • Active substance abuse that would interfere with study evaluation or procedures.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80045

  • Massachusetts General Hospital ACTG CRS

    Boston, Massachusetts, 02114

  • SUNY - Buffalo, Erie County Medical Ctr.

    Buffalo, New York, 14260

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Rush Univ. Med. Ctr. ACTG CRS

    Chicago, Illinois, 60612

  • The Ohio State Univ. AIDS CRS

    Columbus, Ohio, 43210

  • Univ. of Miami AIDS CRS

    Miami, Florida, 33136

  • Beth Israel Med. Ctr. (Mt. Sinai)

    New York, New York, 10003

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Stanford CRS

    Palo Alto, California, 94304

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • Ucsf Aids Crs

    San Francisco, California, 94110

  • University of Washington AIDS CRS

    Seattle, Washington, 98104

  • Washington U CRS

    St Louis, Missouri, 63110

  • St. Louis ConnectCare, Infectious Diseases Clinic

    St Louis, Missouri, 63112

  • Harbor-UCLA Med. Ctr. CRS

    Torrance, California, 90502

Other trials in United States

About this study

Official title: The Antiviral Effect of Switching From Hard Capsule Saquinavir (SQVhc) to the Soft Gelatin Capsule of Saquinavir (SQVsc) Versus Switching to Indinavir (IDV) After 1 Year of Saquinavir Use

To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA.

Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.

Read the detailed description

Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.

Patients who are currently receiving hard capsule saquinavir are randomized to continue receiving hard capsule saquinavir or to switch to soft gelatin capsule saquinavir or indinavir. At week 8, patients receiving the hard capsule formulation will switch to open-label indinavir for weeks 8-24. Patients on the other two arms will remain on their assigned regimen for the entire 24 weeks unless they have no virologic response by week 8, in which case they will be crossed-over to open-label therapy with the alternative drug (i.e., either soft gelatin capsule saquinavir or indinavir).

AS PER AMENDMENT 12/23/96: Viral RNA from weeks 16 and 24 will be assayed in batch after week 24. Patients who exhibit an antiviral response based on this assay will be allowed to continue their current drug assignment for a total of 12 months.

AS PER AMENDMENT 5/7/97: Based on an interim analysis performed after 72 patients had completed 8 weeks of therapy, the study was closed as of March 7, 1997. Patients currently enrolled may stop their participation in the trial and seek other anti-retroviral therapies or may continue on study. Patients on hard capsule saquinavir who remain on study will be switched to indinavir at 8 weeks. Patients on soft gel capsule saquinavir may switch immediately to indinavir or, when results of HIV RNA and CD4 cell counts are available, may choose to switch to indinavir or remain on soft gel capsule saquinavir. Patients receiving indinavir will continue that agent. Follow-up for all patients will end on 7/4/97.

Conditions
HIV Infections
Being tested
Indinavir sulfate, Saquinavir
Keywords
Administration, Oral, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, HIV Protease Inhibitors, Biological Markers, Indinavir, Viremia, RNA, Viral, Saquinavir
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Viremia

What participants receive

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

  • Indinavir sulfateDrug

  • 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 completionOct 1998

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
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000848
Sponsor's protocol ID
ACTG 333
Other IDs
11305
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • Saquinavir update. Treat Rev. 1997 Aug;(No 25):6.

    PubMed 11364616

  • Saquinavir switch study stopped. Treat Rev. 1997 Apr;(No 24):6.

    PubMed 11364285

  • Gilden D. Spring cleaning in trial land. GMHC Treat Issues. 1997 Mar;11(3):4-7.

    PubMed 11364275

  • Para MF, Coombs R, Collier A, Glidden D, Bassett R, Duff F, Boucher C, Leavitt RY, Condra J, Pettinelli C. Relationship of baseline genotype to RNA response in ACTG 333 after switching from long term saquinavir (SQVhc) to indinavir (IDV) or saquinavir soft gelatin capsule (SQVsgc). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:175 (abstract no 511)

  • Sevin AD, DeGruttola V, Nijhuis M, Schapiro JM, Foulkes AS, Para MF, Boucher CA. Methods for investigation of the relationship between drug-susceptibility phenotype and human immunodeficiency virus type 1 genotype with applications to AIDS clinical trials group 333. J Infect Dis. 2000 Jul;182(1):59-67. doi: 10.1086/315673. Epub 2000 Jul 6.

    PubMed 10882582

  • Para MF, Glidden DV, Coombs RW, Collier AC, Condra JH, Craig C, Bassett R, Leavitt R, Snyder S, McAuliffe V, Boucher C. Baseline human immunodeficiency virus type 1 phenotype, genotype, and RNA response after switching from long-term hard-capsule saquinavir to indinavir or soft-gel-capsule saquinavir in AIDS clinical trials group protocol 333. J Infect Dis. 2000 Sep;182(3):733-43. doi: 10.1086/315769. Epub 2000 Aug 14.

    PubMed 10950766

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indinavir sulfate and Saquinavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 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 18 inclusion and 52 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 4 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 16 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.

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 NCT00000848, 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 4 Nov 2021.

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