HIV InfectionsPhase 3NCT00002334
A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment
A Phase 3 study testing Saquinavir, Zidovudine and Zalcitabine in people with HIV Infections, run by Hoffmann-La Roche at 26 sites in 2 countries.
Trial summary
To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens. 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?
- Saquinavir, Zidovudine and Zalcitabine
- How many people
- 3,000 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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:
- Allowed:
- Erythropoietin and G-CSF.
- Concurrent Treatment:
- Allowed:
- Local skin radiotherapy.
Show all 15Show fewer
- Patients must have:
- HIV infection.
- CD4 count 50 - 350 cells/mm3.
- No prior antiretroviral therapy OR less than 16 weeks of prior AZT.
- No acute serious opportunistic infections requiring immediate treatment.
- No unexplained fever persisting for 14 days within 90 days prior to study entry.
- No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry.
- No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy.
- Life expectancy of at least 80 weeks.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malabsorption.
- Severe chronic diarrhea.
- Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort).
- Any grade 3 or worse toxicity.
Show all 23Show fewer
- Inability to comply with study requirements.
- Concurrent Medication:
- Excluded:
- Other investigational agents.
- Antineoplastic agents.
- Biologic response modifiers (including interferons).
- Foscarnet.
- Anti-HIV drugs other than the study drugs.
- Concurrent Treatment:
- Excluded:
- Radiotherapy (other than local skin radiotherapy).
- Patients with the following prior condition are excluded:
- History of non-Hodgkin's lymphoma.
- Prior Medication:
- Excluded:
- Acute therapy for opportunistic infection within 14 days prior to study entry.
- Prior HIV proteinase inhibitor.
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States25 sites
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
Cook County Hosp
Chicago, Illinois, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
Respiratory Associates
Corpus Christi, Texas, 78404
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
Univ TX Galveston Med Branch
Galveston, Texas, 775550882
Thomas Street Clinic / Baylor College of Medicine
Houston, Texas, 77009
HIV Wellness Ctr / Univ Med Ctr
Las Vegas, Nevada, 89102
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
Univ of Miami School of Medicine
Miami, Florida, 331361013
Tulane Univ Med School
New Orleans, Louisiana, 701122699
Beth Israel Med Ctr
New York, New York, 10003
Harkness Pavilion
New York, New York, 10032
Univ of Oklahoma Health Science / Pharmacy Practice
Oklahoma City, Oklahoma, 73117
Phoenix Body Positive
Phoenix, Arizona, 85016
Novum Inc
Pittsburgh, Pennsylvania, 152063817
UCD Med Ctr
Sacramento, California, 95817
Davies Med Ctr
San Francisco, California, 94114
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115
Univ of Washington
Seattle, Washington, 981224379
Pacific Oaks Med Group
Sherman Oaks, California, 91403
Sunnyvale Med Clinic
Sunnyvale, California, 94086
Novum Inc
Washington D.C., District of Columbia, 20037
Howard Univ
Washington D.C., District of Columbia, 20060
Puerto Rico1 site
San Juan Veterans Administration Med Ctr
San Juan, 009275800
About this study
Official title: A Randomized, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3
To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.
Read the detailed description
Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.
- Conditions
- HIV Infections
- Being tested
- Saquinavir, Zidovudine, Zalcitabine
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Saquinavir, HIV Protease Inhibitors
- 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
ZidovudineDrug
ZalcitabineDrug
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 (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 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 3
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 3,000 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002334
- Sponsor's protocol ID
- 229B
- Other IDs
- SV 14604C, SV 14604A
- Status last verified
- Sep 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Collier CA, Coombs RW, Schoenfeld DA, Bassett R, Hooper C, Timphone J, Baruch A, Corey L. A comparative study of saquinavir (SAQ), and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. SAQ, ZDV, and ddC. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:60
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, Multicenter, Double-Blind, Phase III, Parallel Study of Zidovudine (AZT) Alone Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus AZT Plus Saquinavir Mesylate (Ro 31-8959 ; HIV Proteinase Inhibitor) Versus AZT Plus ddC Plus Ro 31-8959 in Previously Untreated or Minimally Pretreated HIV-Infected Patients With CD4 Lymphocyte Counts From 50 to <= 350 Cells/mm3
- ClinicalTrials.gov ID
- NCT00002334
- Acronym / sponsor ID
- 229B
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Saquinavir, HIV Protease Inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 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 compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.
Detailed description
Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Erythropoietin and G-CSF.
- Local skin radiotherapy.
- HIV infection.
- CD4 count 50 - 350 cells/mm3.
- No prior antiretroviral therapy OR less than 16 weeks of prior AZT.
Key exclusion criteria (23 listed)
- Malabsorption.
- Severe chronic diarrhea.
- Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort).
- Any grade 3 or worse toxicity.
- Inability to comply with study requirements.
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 | – |
| Zidovudine | Drug | – |
| Zalcitabine | 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.
- BackgroundCollier CA, Coombs RW, Schoenfeld DA, Bassett R, Hooper C, Timphone J, Baruch A, Corey L. A comparative study of saquinavir (SAQ), and zidovudine (ZDV) vs. ZDV and zalcitabine (ddC) vs. SAQ, ZDV, and ddC. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:60
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saquinavir, Zidovudine and Zalcitabine in people with HIV Infections, run by Hoffmann-La Roche at 26 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 15 inclusion and 23 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 26 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 NCT00002334, 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 24 Jun 2005.