---
title: Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine
nct_id: NCT00808002
overall_status: COMPLETED
phase: PHASE3
sponsor: Germans Trias i Pujol Hospital
study_type: INTERVENTIONAL
primary_condition: HIV Infections
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00808002.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00808002"
ct_last_update_post_date: 2020-01-31
last_seen_at: "2026-05-12T07:10:48.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine

**Official Title:** Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine.

**NCT ID:** [NCT00808002](https://clinicaltrials.gov/study/NCT00808002)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Germans Trias i Pujol Hospital
- **Conditions:** HIV Infections
- **Start Date:** 2009-02
- **Completion Date:** 2011-11
- **CT.gov Last Update:** 2020-01-31

## Brief Summary

The intensification with maraviroc in recently HIV-1-infected patients of a preferred gold-standard triple therapy composed of raltegravir plus tenofovir/emtricitabine could accelerate the decay of the HIV-1 reservoir in latently infected cells established early in HIV-1 infection.

This could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients.

## Detailed Description

A reservoir of latently infected cells established early in infection may be involved in the maintenance of viral persistence despite continuous highly active antiretroviral therapy (HAART). This is likely to represent the major barrier to virus eradication in patients on successful combination antiretroviral therapy.

The majority of the viruses in the latent reservoir use CCR5 receptor during entry.

More recently, clear evidences for decay of this HIV-1 reservoir in patients who initiated antiretroviral therapy early in infection have been demonstrated. The treatment of acute infection may set the stage for subsequent attempts at eradication. To achieve this, more potent antiretroviral therapy and/or more potent antilatency therapies may be needed.

In contrast to previous antiretroviral drugs, maraviroc does not need to cross the cell membrane, nor does not require intracellular processing in order to exert its activity. In addition, there is no cross-resistance between entry inhibitors and agents that act on intracellular targets.

Maraviroc has demonstrated potent antiviral activity against all CCR5-tropic HIV-1 viruses tested. Maraviroc could thus fulfil the requirements for an optimal candidate for treatment intensification in HIV-1 infected patients with a recent HIV-1 infection.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 99 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. HIV-1 infected adults (\>=18 years old).
2. No previous antiretroviral therapy for more than 2 weeks.
3. HIV-1 infection documented in the past 6 months by a previous negative ELISA test, or a documented clinical acute seroconversion in the past 6 months.
4. CCR5-tropism confirmed at screening.
5. Voluntary written informed consent.

Exclusion Criteria:

1. Pregnancy or fertile women willing to be pregnant.
2. Active substance abuse or major psychiatric disease.
3. Presence of NRTI mutations in the screening genotype.
```

## Arms

- **1** (EXPERIMENTAL) — From Baseline to Week48: Raltegravir BID + Tenofovir/Emtricitabine QD + Maraviroc BID From W48 to W72: Raltegravir BID + Tenofovir/Emtricitabine QD
- **2** (ACTIVE_COMPARATOR) — Start ARV treatment with : Raltegravir BID + Tenofovir/Emtricitabine

## Interventions

- **Raltegravir** (DRUG) — Raltegravir 400 mg every 12 hours
- **Maraviroc** (DRUG) — Maraviroc 300 mg every 12 hours
- **Tenofovir/Emtricitabine** (DRUG) — Tenofovir/Emtricitabine 300/200 mg every 24 hours

## Primary Outcomes

- **Change at 48 weeks in the slope of decay of integrated and unintegrated viral DNA in PBMCs.** _(time frame: BL, W2, W4, W12, W24, W48)_

## Secondary Outcomes

- **Decay of residual HIV-1 replication under maraviroc intensification assessed by an ultrasensitive RT-PCR assay with a lower limit of quantification of 5 copies/mL.** _(time frame: BL, W2, W4, W8, W12, W24, W36, W48)_
- **Blips during the study (viral load >50 copies/mL, preceded and followed by determinations <50 copies/mL in previous and posterior controls).** _(time frame: From Baseline to W48)_
- **HIV-1 RNA below 50 copies/mL at 48 weeks.** _(time frame: W48)_
- **Change in the lymphocyte activation marker HLADR+CD38+ from baseline to week 48.** _(time frame: BL, W4, W12, W24, W48, W60, W72)_
- **Relationship between maraviroc and/or raltegravir plasma concentrations and change in the slope of decay of integrated viral DNA in PBMCs** _(time frame: W12, W24, W48)_
- **HIV-1 specific CTL responses** _(time frame: BL, W24, W48, W60, W72)_
- **Plasmatic inflammation biomarkers** _(time frame: BL, W2, W4, W12, W48, W60)_
- **RNA, DNA and viral p24 associated to cells in ileum biopsy and PBMC** _(time frame: W48)_
- **Lymphocyte activation marker HLADR+CD38+ in ileum biopsy and PBMC** _(time frame: W48)_
- **Fibrosis markers in ileum biopsy and PBMC** _(time frame: W48)_

## Locations (2)

- Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
- Hospital Clinic i Provincial de Barcelona, Barcelona, Spain

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital germans trias i pujol|badalona|barcelona|spain` — added _(2026-05-12)_
- `locations.hospital clinic i provincial de barcelona|barcelona||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00808002.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00808002*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*