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TERMINATEDPHASE4

Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals

A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy

NCT00632970•George Washington University

View on ClinicalTrials.gov

Summary

This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.

Detailed Description

It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Documented HIV infection confirmed by western blot or HIV RNA.
•2. At least 18 years of age.
•3. Less than 1 week of prior antiretroviral therapy.
•4. In the opinion of the investigator, patients should be clinically stable. Patients may be on chronic suppressive therapy for opportunistic infections such as MAC or CMV.
•5. Patients who are of reproductive potential agree to use an acceptable method of birth control throughout the study. Acceptable methods include an intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence.
•6. HIV RNA \> 5000 copies/ml. No restriction on CD4 cell count.
•7. A negative urine pregnancy test on the day of initiation of therapy.

Exclusion Criteria

•1. Prior treatment with \>1week of antiretroviral therapy.
•2. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
•3. HIV RNA \< 5000 prior to receiving therapy.
•4. Baseline resistance to any of the study regimen drugs on genotype testing.
•5. Patients with acute hepatitis due to any cause or clinically significant chronic liver disease.
•6. Patient with severe renal insufficiency defined as a calculated creatinine clearance at time of screening \<30mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85X this value for females): Clcr(mL/min) = (l40-age) x weight (in kg)72 x serum creatinine (mg/dL).
•7. Patient has a condition (including but not limited to alcohol or other substance abuse) which in the opinion of the investigator would interfere with patient compliance or safety.
•8. A female patient who is pregnant, breast-feeding, or expecting to conceive or donate eggs during the study; or a male patient who is planning to impregnate or provide sperm donation during the study is excluded.
•9. Inability to obtain signed informed consent from a patient age 18 or older.
•10. Patient has significant hypersensitivity or other contraindication to any of the components of the study drug.
+1 more criteria

Locations (1)

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

Key Dates

Start Date

February 1, 2008

Primary Completion Date

February 1, 2010

Completion Date

June 1, 2010

Last Updated

August 29, 2018

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

Raltegravir

DRUG

Lopinavir/Ritonavir

DRUG

Truvada

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Energetics and Fatiguability in Older Individuals

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