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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

Phase 3
16 Years
Not Enrolling
HIV Infections

Thank you

Trial Information

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

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

** 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

Inclusion Criteria

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:



- 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.


- <= 2 weeks cumulative treatment with protease inhibitors.



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

- 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.)


- Note:

- 50% of the patients will be treatment naive and 50% will be NRTI experienced. AS PER
AMENDMENT 12/12/97.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • 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
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



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