Clinical Trial to Evaluate the Effect of Raltegravir Intensification (1.200 mg QD) on the Gut Microbiota of Chronically HIV-1 Infected Subject Over Time: THE RAGTIME STUDY

• Status: Completed
• Trial end date: 2020-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The project presented here will be the first prospective, randomized evaluation of the effect of ART on the structure and function of the gut microbiome. This study provides a unique opportunity to understand the benefits of ART with high intestinal penetration on the gut microbiome. It is thus a key study to understand the bidirectional interactions between the microbiome and the host in people living with HIV/AIDS.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Raltegravir Potassium

Criteria

Inclusion Criteria:

1. Age ≥18 years old

2. Documented HIV infection

3. Stable 3-drug antiretroviral treatment including PI/r/c or NNRTI for at least 6 months.

4. Plasma HIV-1 RNA load <50 copies/mL for at least 12 months.

5. Signed Informed Consent

Exclusion Criteria:

1. PI/r monotherapy

2. INSTI therapy during the previous 6 months

3. Evidence of previous INSTI resistance

4. Creatine clearance <50 mL/min

5. Child- Pugh B or C

6. History of active uncontrolled GI disorders or diseases including:

6.1. Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the previous 5 years.

6.2. Any major bowel resection at any time.

6.3. Any chronic digestive disease such as peptic ulcer, Crohn's disease, ulcerative colitis, coeliac disease, confirmed intolerance to lactose or indeterminate colitis.

6.4. Persistent infectious gastroenteritis, colitis or gastritis; persistent or chronic diarrhea of unknown etiology; Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated)

6.5. Irritable bowel syndrome (moderate-severe)

6.6. Chronic constipation

6.7. Active proctitis

7. Antibiotic therapy within the previous 2 months

8. In women, pregnancy or breastfeeding*.

• Female subjects of childbearing potential must not be pregnant, not be planning a pregnancy or breast-feeding. Sexually active women must be willing to use two approved methods of contraception (including condoms, diaphragm, spermicides, hormonal methods and/or intrauterine devices) from baseline until the end of the clinical trial. Sexually active men in heterosexual relationships must be willing to use two approved method of contraception with their partners from baseline until the end of the clinical trial.

• condom use is considered as an additional method of contraception only and cannot be the only method of contraception used as not been considered an effective method by the Clinical Trial Facilitation Group (CTFG) guidelines.