A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00100984

Enrollment

Registered

2005-01-10

Start date

2004-07-21

Completion date

2005-07-16

Last updated

2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Brief summary

The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.

Interventions

DRUGFUZEON [enfuvirtide]

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* CD4 cell count greater than 50 cells/mm\^3 * HIV-1 RNA viral load greater than or equal to 5000 copies/mL * Patients must be HIV treatment experienced * Patients diagnosed with HIV-1 infection

Exclusion criteria

* Female patients must not be able to have children or must be under effective contraceptives * Female patients who are pregnant * Have taken enfuvirtide and/or T-1249 before * Have serious kidney problems * Alcohol and/or drug abuse * Have had an organ transplant

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026