Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100
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ClinicalTrials.gov Identifier: NCT00385957 |
Recruitment Status
:
Completed
First Posted
: October 11, 2006
Last Update Posted
: December 15, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: AZT+3TC+IDV+RTV Drug: AZT+3TC+EFV | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Antiretroviral Activity and Immunological Effect of Two Triple Treatments With and Without Protease Inhibitors in naïve HIV-1-infected Patients With CD4 < 100/mm3 |

- Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.
- Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.
- Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive
- CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)
- and levels of CD8 cells (CD28+ y CD38+)
- Incidence of adverse events

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed HIV-1 infection.
- Age 18 years or over.
- No previous antiretroviral therapy.
- CD4 lymphocyte count of < 100 cells/mL.
- Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study.
Exclusion Criteria:
- Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period.
- Currently undergoing treatment for an opportunistic infection (parenteral administration).
- Any formal contraindication to treatment with the study drugs

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385957
Spain | |
CSU Bellvitge | |
Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
Donostia Ospitaleak | |
San Sebastian, Giputzkoa, Spain, 20014 | |
Hospital de la Santa Creu i Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Clinic | |
Barcelona, Spain, 08036 | |
Hospital Universitario La Paz | |
Madrid, Spain, 28046 |
Study Chair: | Jose M Gatell, MD | Hospital Clinic of Barcelona |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00385957 History of Changes |
Other Study ID Numbers: |
ADVAN-Z |
First Posted: | October 11, 2006 Key Record Dates |
Last Update Posted: | December 15, 2010 |
Last Verified: | October 2006 |
Keywords provided by Hospital Clinic of Barcelona:
Treatment Naive |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Lamivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |