A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
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Purpose
To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the treatment regimens.
AS PER AMENDMENT 12/12/97: To compare the virologic response of Fortovase (FTV) (Saquinavir) Soft Gel Capsule (SGC) tid plus nucleoside reverse transcriptase inhibitors (NRTIs) versus FTV bid plus NRTIs. Further, to compare the virologic response of FTV tid plus NRTIs versus FTV bid plus Nelfinavir bid plus a NRTI with respect to: the percentage of patients whose plasma HIV-1 RNA level falls below the Amplicor assay level of detection (< 400 copies/ml) at week 24 and week 48.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Saquinavir Drug: Delavirdine mesylate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Randomized Phase IIIB Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Plus Nelfinavir BID Plus a NRTI in HIV-1 Infected Patients |
| Estimated Enrollment: | 825 |
Patients will be randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) sgc plus 2 new reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus new RTI, and Group C - SQV sgc plus nelfinavir plus new RTI, or SQV sgc plus ritonavir plus 2 new RTIs.
NOTE: "New RTI" is defined for this study as any reverse transcriptase inhibitor to which the patient has never been exposed.
AS PER AMENDMENT 12/12/97: In this open-label, multicenter, Phase IIIB, comparative study, 825 patients are randomized to treatment arms. (NOTE: 50% of the patients will be treatment naive and 50% will be NRTI experienced.) Further, patients are randomized with stratification based on HIV-1 RNA level (5,000-30,000 copies/ml vs. greater than 30,000 copies/ml) and prior antiretroviral therapy to one of the three study arms.
The drug regimens for the three treatment arms are as follows:
ARM A: Fortovase (FTV), plus 2 new NRTIs*. ARM B: FTV plus 2 new NRTIs*. ARM C: FTV plus nelfinavir plus new NRTI**.
Naive patients in Arm A and Arm B will take: d4T (or zidovudine) plus 3TC unless contraindicated.
** Naive patients in Arm C will take: d4T, unless contraindicated.
- NRTI experienced patients in Arms A & B should be treated with 2 NRTIs to which he/she has not been previously exposed. If the patient has only 1 NRTI to which he/she has never been exposed, then the second NRTI can be one that the patient has been previously exposed to from the most distant past.
Therapy is administered for an initial 24 weeks and may be extended for an additional 24 weeks.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
- HIV-1 infection.
- HIV RNA >= 5000 copies/ml by Amplicor assay.
- Signed, informed consent from parent or legal guardian for patients less than 18 years old.
Prior Medication:
Required:
(Note:
- 50% of the patients will be treatment naive).
- > 3 months cumulative therapy with antiretrovirals other than non-nucleoside reverse transcriptase inhibitors and/or protease inhibitors.
- Stable antiretroviral therapy for at least 4 weeks prior to enrollment.
Allowed:
- <= 2 weeks cumulative treatment with protease inhibitors.
AS PER AMENDMENT 12/12/97:
Required:
NRTI experienced patients:
- > 3 months cumulative therapy with antiretrovirals.
- <= 2 weeks cumulative previous treatment with non-nucleoside analogue reverse transcriptase inhibitors (NNRTIs).
- <= 2 weeks cumulative previous treatment with protease inhibitors.
- Must have at least one NRTI (preferably two) to which he/she has not been previously exposed.
- Stable antiretroviral therapy defined as within (+/-) 1 log HIV-1 RNA between the 2 most recent values greater than 8 weeks apart (may include screening visit) prior to study enrollment. (NOTE:
- If patient does not have a previous HIV-1 RNA value, screening will be accepted.)
Required:
- Note:
- 50% of the patients will be treatment naive and 50% will be NRTI experienced. AS PER AMENDMENT 12/12/97.
Contacts and Locations
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| ClinicalTrials.gov Identifier: | NCT00002378 History of Changes |
| Other Study ID Numbers: | 229H, NR15520, M6101 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
HIV-1 Drug Therapy, Combination Zidovudine Stavudine HIV Protease Inhibitors Lamivudine RNA, Viral |
Dosage Forms Saquinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Nelfinavir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Stavudine Lamivudine Reverse Transcriptase Inhibitors |
Delavirdine Saquinavir Ritonavir Nelfinavir HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 21, 2013