HIV InfectionsPhase 2NCT00002162
A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs
A Phase 2 study testing Saquinavir, Lamivudine and Stavudine in people with HIV Infections, run by Hoffmann-La Roche at 27 sites in 2 countries.
Trial summary
To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Saquinavir, Lamivudine and Stavudine
- How many people
- 140 participants
- Where
- 27 sitesin 2 countries
- Study dates
- Start not givento not given
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- HIV infection.
- Antiretroviral naiveness (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs.
- No more than 2 weeks of prior treatment with a protease inhibitor.
- No active opportunistic infection or other serious AIDS-defining condition.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malabsorption or inadequate oral intake.
- Lab or clinical abnormality worse than grade 3 (other than exercise-induced CPK elevations).
- Unexplained, chronic diarrhea, defined as more than three loose stools per day persisting for 2 weeks or more within the month prior to study entry.
- Active malignancy or anticipated need for chemotherapy during the study.
Show all 14Show fewer
- Anticipated need for disallowed medications during the study.
- Concurrent Medication:
- Excluded:
- Other protease inhibitors.
- Prior Medication:
- Excluded:
- More than 4 weeks of the prior nucleoside antiretroviral selected for the patient's regimen.
- More than 2 weeks of any protease inhibitor.
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States23 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
New England Med Ctr
Boston, Massachusetts, 02111
Harvard Univ / Massachusetts Gen Hosp
Boston, Massachusetts, 02114
Cook County Hosp
Chicago, Illinois, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Univ of Texas Med Branch
Galveston, Texas, 775550835
Infectious Diseases Association of Houston
Houston, Texas, 77030
UCLA AIDS Clinical Research Ctr / Dept of Medicine
Los Angeles, California, 90024
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, 70122
Beth Israel Med Ctr
New York, New York, 10003
St Vincents Hosp and Med Ctr / AIDS Cntr Progrm
New York, New York, 10011
Univ of Oklahoma
Oklahoma City, Oklahoma, 73117
AIDS Research Ctr
Palo Alto, California, 94304
Univ of Pennsylvania / Division of Infectious Disease
Philadelphia, Pennsylvania, 19104
Phoenix Body Positive
Phoenix, Arizona, 85016
UCD Med Ctr
Sacramento, California, 95817
UCSD Treatment Ctr
San Diego, California, 921036329
Mount Zion Hosp of UCSF
San Francisco, California, 94115
San Francisco Veterans Adm Med Cntr
San Francisco, California, 94121
Saint Joseph's Hosp
Tampa, Florida, 33614
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
Canada4 sites
Southern Alberta HIV Clinic / Foot Hills Hosp
Calgary, Alberta
McMaster Univ Med Ctr
Hamilton, Ontario
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec
Saint Paul's Hosp / Canadian HIV Trials Network
Vancouver, British Columbia
About this study
To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
Read the detailed description
Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.
- Conditions
- HIV Infections
- Being tested
- Saquinavir, Lamivudine, Stavudine, Zidovudine, Zalcitabine
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Saquinavir
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaquinavirDrug
LamivudineDrug
StavudineDrug
ZidovudineDrug
ZalcitabineDrug
DidanosineDrug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002162
- Sponsor's protocol ID
- 229D
- Other IDs
- NV15355
- Status last verified
- Aug 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
PubMed 11364377Mitsuyasu RT, Skolnik PR, Cohen SR, Conway B, Gill MJ, Jensen PC, Pulvirenti JJ, Slater LN, Schooley RT, Thompson MA, Torres RA, Tsoukas CM. Activity of the soft gelatin formulation of saquinavir in combination therapy in antiretroviral-naive patients. NV15355 Study Team. AIDS. 1998 Jul 30;12(11):F103-9. doi: 10.1097/00002030-199811000-00001.
PubMed 9708399
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs
- ClinicalTrials.gov ID
- NCT00002162
- Acronym / sponsor ID
- 229D
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Saquinavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- 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.
To evaluate the antiviral activity and safety of two formulations of saquinavir in combination with licensed nucleoside antiretroviral drugs.
Detailed description
Patients are randomized to receive either hard gel or soft gel capsules of saquinavir in combination with at least one licensed nucleoside antiretroviral. Treatment will continue for 48 weeks. After the first 16 weeks, patients will be given the opportunity to roll over to the saquinavir formulation of choice.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- HIV infection.
- Antiretroviral naiveness (i.e., less than 4 weeks of prior treatment) to at least one of the licensed nucleoside drugs.
- No more than 2 weeks of prior treatment with a protease inhibitor.
- No active opportunistic infection or other serious AIDS-defining condition.
Key exclusion criteria (14 listed)
- Malabsorption or inadequate oral intake.
- Lab or clinical abnormality worse than grade 3 (other than exercise-induced CPK elevations).
- Unexplained, chronic diarrhea, defined as more than three loose stools per day persisting for 2 weeks or more within the month prior to study entry.
- Active malignancy or anticipated need for chemotherapy during the study.
- Anticipated need for disallowed medications during the study.
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 |
|---|---|---|
| Saquinavir | Drug | – |
| Lamivudine | Drug | – |
| Stavudine | Drug | – |
| Zidovudine | Drug | – |
| Zalcitabine | Drug | – |
| Didanosine | 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 24 Jun 2005.
- Background: PubMed 11364377Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.
- Background: PubMed 9708399Mitsuyasu RT, Skolnik PR, Cohen SR, Conway B, Gill MJ, Jensen PC, Pulvirenti JJ, Slater LN, Schooley RT, Thompson MA, Torres RA, Tsoukas CM. Activity of the soft gelatin formulation of saquinavir in combination therapy in antiretroviral-naive patients. NV15355 Study Team. AIDS. 1998 Jul 30;12(11):F103-9. doi: 10.1097/00002030-199811000-00001.
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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.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Saquinavir, Lamivudine and Stavudine in people with HIV Infections, run by Hoffmann-La Roche at 27 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 5 inclusion and 14 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Canada. 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 NCT00002162, which also lists 2 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 24 Jun 2005.