A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients

• Register: ClinicalTrials.gov
• 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
• URL: http://clinicaltrials.gov/show/NCT00002378
• 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:

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.



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Delavirdine mesylate

Drug: Lamivudine

Drug: Nelfinavir mesylate

Drug: Ritonavir

Drug: Saquinavir

Drug: Stavudine

Drug: Zidovudine

Secondary ID(s)

229H

M6101

NR15520

Source(s) of Monetary Support

Please refer to primary and secondary sponsors