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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT00002378
Date of registration: 02/11/1999
Primary sponsor: Hoffmann-La Roche
Public title: A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
Scientific 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
Date of first enrolment: June 1996
Target sample size: 825
Recruitment status: Completed
Study type:  Interventional
Study design:  Endpoint Classification: Safety Study, Primary Purpose: Treatment  
Countries of recruitment
Germany Italy Puerto Rico Spain United Kingdom United States
Key inclusion & exclusion 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.

Age minimum: 16 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
HIV Infections
Drug: Delavirdine mesylate
Drug: Lamivudine
Drug: Nelfinavir mesylate
Drug: Ritonavir
Drug: Saquinavir
Drug: Stavudine
Drug: Zidovudine
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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