Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.

A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00386659

Enrollment

Registered

2006-10-11

Start date

Unknown

Completion date

Unknown

Last updated

2006-10-11

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

Conditions

HIV Infection

Brief summary

Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.

Interventions

DRUGtenofovir + abacavir + lopinavir/ritonavir

DRUGtenofovir + abacavir + efavirenz

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* HIV-infection * Antiretroviral-naive * CD4 cell count below 100 cells/mm3

Exclusion criteria

* Pregnancy * Current opportunistic infection requiring parenteral therapy * Current malignancies requiring parenteral chemotherapy * Any contraindication to the study drugs

Design outcomes

Primary

Measure	Time frame
Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.	—

Secondary

Measure	Time frame
Degree and kinetics of recovery of the immune system.	—
New CDC C events	—
Mortality	—

Countries

Spain

Outcome results

None listed

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