Vicriviroc in HIV-Treatment Experienced Subjects

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-059-07
• Lead Sponsor: SCHERING PLOUGH DEL PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-10-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. The subject must give written informed consent before entering the selection stage for this study.
2. The subject must be willing and able to comply with the schedules of administration of doses and visits.
3. The subject must be at least 16 years of age at the time of randomization and be of any sex or race.
4. The subject must be infected with the HIV-1 virus.
5. The subject must present> 1000 copies / ml of HIV-1 RNA in plasma within 60 days of randomization.
6. Subjects must have received antiretroviral therapy (ART) beforehand and have confirmed resistance to at least 2 of the following 3 classes of drugs; NRTls, NNRTls or lPs. Or have been treated for at least 6 months with each of the following classes of antiretrovirals: NRTls, NNRTls, IPs.
7. Subjects should be willing to start a new optimized base treatment (OBT) that contains at least 3 drugs at the time of randomization.
8. The QTc interval should be <470 ms for women and <450 ms for men.
9. Subjects must present acceptable hematological, renal and hepatic laboratory values.
10. Women of childbearing age should agree to use a contraceptive method accepted medically.
11. Women of childbearing age who are not having sex should agree to use a contraceptive method medically accepted if they become sexually active during their participation in the study. Postmenopausal women are exempt from the requirement to use
contraceptives
12. The subject must be willing to start chemoprophylaxis.

Exclusion Criteria

1. Subjects with strains of HIV with tropism CXCR4 or tropism CCR5 / CXCR4 dual / mixed detectable in the selection stage.
2. Subjects with a history of cancer.
3. Subjects with seizure disorders requiring continued anticonvulsant therapy or with any condition that may increase the risk of seizures.
4. Subjects whose use of any drug, or in whom abstinence from it presents an increased risk of seizures.
5. Subjects with a serious illness.
6. Subjects with known liver cirrhosis or with symptoms, clinical signs, or abnormal laboratory values ​​indicative of cirrhosis.
7. Subjects with intercurrent diseases, who have received vaccines or used immunomodulators that could influence plasma HIV-1 RNA levels.
8. Subjects who have previously been enrolled in any clinical trial with vicriviroc or who have previously used a CCR5 Inhibitor for> 4 weeks and / or within 30 days of the Screening visit.
9. Subjects who have received any of the certain prohibited treatments while they are still in the indicated washout period.
10. Subjects with allergy / hypersensitivity to the study drug or its excipients.
11. Women who are breastfeeding, pregnant or who intend to become pregnant.
12. Subjects with any clinically relevant condition or situation other than the condition being studied.
13. Subjects that are members or relatives of staff members directly involved in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified