HIV InfectionsPhase 3NCT00002367
A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
A Phase 3 study testing Saquinavir, Lamivudine and Zidovudine in people with HIV Infections, run by Hoffmann-La Roche at 2 sites in United States.
Trial summary
To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Saquinavir, Lamivudine and Zidovudine
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Plasma HIV-1 RNA titers > 10,000 copies/ml.
- CD4 cell count > 100 cells/mm3.
Who cannot join
- Co-existing Condition:
- Patients with any of the following conditions will be excluded:
- Any prior anti-retroviral drug therapy.
- Prior Medication:
- Excluded:
- Previous anti-retroviral drug therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Urgent Care Ctr / North Broward Hosp District
Fort Lauderdale, Florida, 33316
AIDS Healthcare Foundation Labs
Los Angeles, California, 90048
About this study
Official title: An Open-Label, Non-Comparative Study of Saquinavir-SGC in Combination With Zidovudine (AZT) and Lamivudine (3TC) in the Treatment of HIV-1 Infected Patients With No Previous Anti-Retroviral Drug Therapy
To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.
Read the detailed description
All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.
- Conditions
- HIV Infections
- Being tested
- Saquinavir, Lamivudine, Zidovudine
- Keywords
- Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, HIV Protease Inhibitors, Lamivudine, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaquinavirDrug
LamivudineDrug
ZidovudineDrug
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.
- 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
- Intervention model
- Parallel groups
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002367
- Sponsor's protocol ID
- 229F
- Other IDs
- NR15503, M61005
- Status last verified
- Aug 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No